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Post Name: Production (Injectables)/ Packing (Injectables)/Warehouse (Injectables)
Qualification: Pharm/ M Pharm/ BSc/ ITI/ Diploma in Engineering / Pharmacy/b.com
Experienced:0-2 years
Important Details :
Location: our Injectable Manufacturing facility at Kotambi, Nr. VCA stadium, Vadodara, Gujarat-391510
Post of date:22/09/2023
Selection Process: The selection will be on the basis of Interview.
Mode of Interview: Face To Face Interview
Interview Rounds of Interview: HR
Walk-in Interview Details
The opportunity for above opens with “Walk In Interview” on 25th September 2023,between 11:00 to 16:00 hours at Admin Office, 2nd Floor, Innoxel Lifesciences, Survey No. 534/1, Near VCA stadium, Kotambi, Vadodara for below positions:
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Officers (B. Pharm, M. Pharm), Fresher or 1 to 2 years experiences
Operators (ITI, Diploma in Engineering / Pharmacy) Fresher and 1 to 2 years experiences
Sr. Executive (B. Pharm, M. Pharma), minimum 6 years experiences in QMS
2) Packing (Injectables)
Officers (B. Sc., B. Pharm, M. Pharm), Fresher or 1 to 2 years experiences
Operators (ITI, Diploma in Engineering / Pharmacy) Fresher and 1 to 2 years experiences
3) Warehouse (Injectables)
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At our R&D Centre in Navi Mumbai, we are looking for Formulation Development Scientist.
About company:
IQGenX, established in 2017 by pharma industry veterans, is a leading Contract Research Organization (CRO) based in Mumbai. With our guiding principles of Innovation, Quality and Excellence; we have been able to successfully complete technology transfer for over 15 products with a “First-Time-Right” approach. Our Clients/Partners filed more than 6 ANDAs for the US market as of now with about 6 more in advanced stage of submission. Our Clients/Partners trust our capabilities and expertise to develop, scale-up and commercialize niche and complex oral and injectable products.
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JOB DESCRIPTION
Area of work: Formulation Research and Development
Experience: 0-5 years.
Job Responsibilities:
1) Literature search for assigned projects. 2) Technical background and understanding of formulation development, Design of experiments, QbD principles etc.
3) Formulation development for dosage forms like solid orals, Injectable, liquid oral formulations etc.
4) Hands of experience on major equipment from R&D to Scale up level.
5) Planning and execution of development trials independently.
6) LNB writing, maintenance of raw material and equipment usage logbook recording.
7) Co-ordination with CFT members (Analytical team) for routine analytical planning and sample support for the same.
8. Routine analytical data compilation and maintenance.
9) Preparation and review of stability study protocols, PDR, MFC, MPC, miscellaneous study protocols, SOPs and relevant CMC sections for various regulatory filings, etc.
10) Lab management activities like routine calibration, qualifications, and maintenance of instruments/ equipments.
11) Inventory control and management. 12) Pilot batch, Scale-up, Pre-exhibit and Exhibit batches planning, execution and documentation. 13) Assistance in validation activities.
Please send your application and resume to
Contactus@iqgenx.com
QbD- Quality by Design in pharmaceutical product development
Benefits after Course:
👍Add on skills
👍QbD Aspects and approaches.
👍learn full QbD concept optimisation and risk assessment.
👍Become Expert in R&D.
👍Quick Analyze problems.
👍Lifetime access and certificate.
We at Encube Ethicals are hiring for Regulatory Affairs Department.
Qualification: M.Pharm/ M. Sc.
Experience: 3-8 years.
Location: Andheri (Marol), Mumbai.
Roles and Responsibilities:
1. eCTD Publishing of ANDAS for US Market, EU market and other market.
2. Labeling activities like preparation of artworks mockups, creation of SPL.
3. Review of the documents.
4. Database Management.
Desired Candidate Profile
1. Experience in handling eCTD software like PharmaReady
2. Experience in handling SPL software like PharmaReady
3. Basic awareness of CTD structure and review of the documents from eCTD operations perspective.
4. Basic awareness of regulatory operations and functions.
5. Positive Attitude and Approach. Learning Abilities
Interested candidates can share their resumes on jeel.c@encubeethicals.com
Most urgent openings for Sr. Manager-Project Management
Qualification: Bpharma/Mpharma/PharmaD
Vacancy: Operations-Pharmacovigilance.
Experience: 8+years Location: Hyderabad
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Required Skills:
✅Process adverse event information received by the Drug Safety and Pharmacovigilance department and assist in the preparation of internal and external reports. Ensures effective functioning of all PV projects in compliance with client agreement, contract; and local and global regulatory guidelines.
✅Track the audit and responses and reports audit status to management on regular bases in compliance with GVP. Holds responsibilities of executing actions of pharmacovigilance systems and quality systems Mitocon Policies.
✅Co-ordinate and perform audit for cross-functional departments and support QA team.
✅Regular Monitoring of department workload and alerts the Team Manager/Designee in case of any problems relating to internal staff workload that may affect the quality and deliverables being undertaken.
✅Co-ordinate internal resources for accurate execution of projects and deliver results to meet the client expectations.
✅Develop and drive the quality review/sampling of ICSRS, literature, signal team and aggregate reports as part of quality management system.
👉Interested candidates kindly call on 9154383165 (No Calls on Saturdays and Sundays) or share your resume to hr@mitoconbiopharma.com
Nitrosamine compounds are potent genotoxic agents in several animal species and some are classified as probable or possible human carcinogens by the International Agency for Research on Cancer (IARC).
Background:
👉Since 2018, several drug products including ARBs, ranitidine, nizatidine, and metformin have been found to contain unacceptable levels of nitrosamines.
👉In June 2018, FDA was informed of the presence of an impurity identified as Nnitrosodimethylamine (NDMA) in the ARB valsartan.
👉In September 2019, FDA learned that some common heartburn products (ranitidine, commonly known as Zantac, and nizatidine, commonly known as Axid) contained unacceptable levels of NDMA.
👉In December 2019, FDA became aware that some metformin diabetes medicines in other countries were reported to have NDMA.
👉The term nitrosamine describes a class of compounds having the chemical structure of a nitroso group bonded to an amine (R1N(-R2)-N=O)
Possible ways or sources of Nitrosamine Impurities:
✅General Conditions That Lead to Nitrosamine Formation:
1) Formation of nitrosamines is possible in the presence of secondary, tertiary, or quaternary amines and nitrite salts under acidic reaction conditions.
2) Nitrites used as reagents in one step can carry over into subsequent steps, despite purification operations, and react with amines to generate nitrosamine impurities.
3) Secondary and tertiary Amines may be present in a manufacturing process for a variety of reasons.
4) Amide solvents, which are susceptible to degradation under certain reaction conditions, are another source of secondary amines. For example, under high reaction temperatures for an extended reaction period, N,N-dimethylformamide can degrade into dimethylamine, which can react with nitrous acid to form NDMA.
This list of the aforementioned sources is not exhaustive, as amine reagents can be used to mediate a wide range of synthetic transformations. Manufacturers should evaluate other reagents containing amine functional groups for potential risk of nitrosamine formation.
✅Contamination in Vendor-Sourced Raw Materials:
Nitrosamine impurities can be introduced when vendor-sourced materials, including starting materials and raw materials, are contaminated, The Agency has observed the following contaminations due to this root cause:
1) Nitrosamine contamination has occurred when fresh solvents (ortho-xylene, toluene, and methylene chloride) were contaminated during shipment from vendors (e.g., during transfer between storage vessels).
2) Presence of Sodium nitrite is a known impurity in some starting materials.
3) Presence of Nitrate-containing raw materials, such as potassium nitrate, may contain nitrite impurities.
4) Starting materials or outsourced intermediates may be at risk through cross-contamination (if they are manufactured at sites where nitrosamine impurities are produced in other processes).
✅ Recovered Solvents, Catalysts, and Reagents as Sources of Contamination:
1) API Manufacturing involves synthetic process which produces nitrosamines or contains precursor amines.
2) It was reported that ortho-xylene and toluene were contaminated during recovery due to inadequate cleaning and to use of shared storage equipment between different customers.
3) Inadequate and unvalidated cleaning procedures can also lead to crosscontamination.
✅ Lack of Process Optimization and Control:
Nitrosamine impurities is lack of optimization of the manufacturing process for APIs when reaction conditions such as temperature, pH, or the sequence of adding reagents, intermediates, or solvents are inappropriate or poorly controlled.
These limits are applicable only if a drug product contains a single nitrosamine. If more than one of the nitrosamine impurities identified in Table 1 is detected and the total quantity of nitrosamine impurities exceeds 26.5 ng/day (The Acceptable Intake (AI) for the most potent nitrosamines) based on the maximum daily dose (MDD), the manufacturer should contact the Agency for evaluation.
🔖For drug products with an MDD (Maximum Daily Dose) of less than 880 mg/day, a recommended limit for total nitrosamines of 0.03 ppm is not more than 26.5 ng/day and is considered acceptable.
🔖For drug products with an MDD above 880 mg/day the limit for total nitrosamines should be adjusted so as not to exceed the recommended limit of 26.5 ng/day.
Products should use methods with LOQs at or below 0.03 ppm. If more than one nitrosamine listed in Table 1 is detected, then the analytical method should be validated for LOQs below 0.03 ppm to accurately quantify a total nitrosamine level of not more than 26.5 ng/day. For example, if the MDD is 1200 mg, the LOQ should be below 0.02 ppm.
Recommendations:
Because nitrosamines are probable or possible human carcinogens, FDA recommends that manufacturers consider the potential causes of nitrosamine formation described in this guidance as well as any other pathways observed and evaluate the risk for nitrosamine contamination or formation in their APIs and drug products. Manufacturers should prioritize evaluation of APIs and drug products based on factors such as maximum daily dose, duration of treatment, therapeutic indication, and number of patients treated. As new information becomes available and FDA’s understanding of nitrosamines in drugs evolves.
Pharma Drug Regulatory Affairs Course-2023
👉Apply Offer link : Click here
Commonly asked Regulatory Affairs Questions and answer click here
Overview of Regulatory affairs
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies.
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About company:
Aizant® is an integrated drug development solutions provider.We are a rapidly growing contract research organization (CRO) with a diverse portfolio of capabilities partnering with health care companies specializing in new molecular entities (NME's), generics (ANDA's) and over the counter (OTC's) products globally.
Date: Friday 25 Aug,2023 Timing- 9.00 a.m to 12.00 p.m
Open Positions- Technical Trainees
Qualification- M. Pharmacy (Pharmaceutics)
Passing out Year- 2020 to 2023
Department- Formulation Development
Venue: Aizant Drug Research Solutions Pvt Ltd, Apparel park road, Dullapally, Dundigal, Medchal, Hyderabad-500100
Those who are unable to attend the interview can send their resume to careers@aizant.com
QbD- Quality by Design in pharmaceutical product development
Benefits after Course:
👍Add on skills,
👍QbD Aspects and approaches.
👍learn full QbD concept.
👍Become Expert R&D.
👍Quick Analyze problems.
👍Lifetime access and certificate.
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Description:
As a Clinical Research Executive at QPS Bioserve, your role will involve a variety of responsibilities to ensure smooth study conduct and compliance. Here are some of the tasks you’ll be involved in:
🔖Ensuring readiness of clinical units, emergency units, and equipment for study activities.
🔖Organizing regulatory documents, approved protocols, and informed consent forms in the Trial Master File.
🔖Arranging study-related documents as per protocol requirements.
🔖Coordinating subject enrollment during check-in and study completion.
🔖Performing study-related activities in line with GCP, principles, ethics, and regulatory requirements.
🔖Obtaining and documenting informed consent from subjects.
🔖Conducting subject training on study procedures.
🔖Coordinating with investigators for drug administration.
🔖Administering investigational drug products to subjects.
🔖Coordinating with clinical staff for various activities as per protocol.
🔖Reporting adverse events and coordinating with investigators.
🔖Ensuring subject compliance with study activities.
🔖Accurate transcription of data from source documents.
Job Details:
For clinical research Guidance and interview preparation enroll our online course.
Phases of Clinical Trials:
When clinical research is used to evaluate the medications and medicinal devices, Clinical trials are kind of clinical research design to evaluate and test new interventions such as psychotherapy or medications.
Types of Clinical Trial Phases:
Phase I - safety and safe dose range (Tolerance determination)
Phase II- Safety and Efficacy
Phase III- Safety, Efficacy and Toxicity
Phase IV- Post market surveillance
Types of Clinical Research:
Treatment research generally involves intervention such as psychotherapy, medications, new medicinal devices, new approaches to sergery or radiation therapy.
Prevention research looks for better ways to prevent disorders from developing and returning. Different types of prevention main study medicines, vitamins, vaccines, minerals or lifestyle changes.
Diagnostic research refers to practice of looking for better to identify a particular disorder or condition .
Screening research aims to find best way to detect specific disorder or health condition
Let's explain in short each clinical phase:
Phase I: in this phase of clinical study small group (10 subjects) of healthy volunteers will be used for determination of safety and the dose range for new drugs for development.
Phase II: in this phase of clinical study small group (50-100) of patients will be used for determination of safety and efficacy for new drugs for development which will be used for specific disease or disorder.
Phase III: in this phase of clinical study more patients (300-1000) will be used for determination of safety and efficacy and Toxicity levels (adverse side effects) for new drugs for development which will be used for specific disease or disorder.
Phase IV: Find more information about long-term side effects.
In Phase IV trials, doctors study treatments that the FDA has already approved. The goal of Phase IV trials is to continue studying side effects of a new treatment.
CLINEXEL is a Contract Research organization providing end-to-end services in Clinical Development, Clinical operations, medical writing, and Pharmacovigilance. Our clients include Pharma, Biotech, and Medical Device companies based in India, Europe, the US, Canada, Israel, and Singapore.
Experience: 1-2 years
Skills required: Candidates should have strong knowledge of clinical trials (Phase I to Phase IV) national and global Clinical Trials
Job location: Navi Mumbai (office based job)
Immediately joiners will get preferred
Interested can share CV on careers@clinexel-cro.com
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Career in Pharmaceutical Medical writing
What is a medical writer?
Medical writers work alongside scientists, doctors and other healthcare professionals to produce physical and online medical documents for educational, promotional or informative purposes.
Job description
Medical writers are required within a range of different settings such as within CROs, pharmaceutical companies and medical communications agencies, therefore exact responsibilities will vary. As a general rule, they write a range of clinical documents from initiation to completion, producing high-quality, clear and accurate work. They may also be required to contribute to document quality control (reviewing data accuracy, formatting and appropriateness of language, and compliance to industry guidelines) as well as evaluate the data to be included within documentation.
They can be involved in writing:
🔖Clinical trial protocols and publications
🔖Study reports
🔖White papers
🔖Consumer drug/medical device information
🔖Magazine and newspaper articles
🔖Medical and healthcare advertisements
🔖Insurance policy documents
🔖Medical books
🔖Advice leaflets and websites
🔖Press releases
Types of employers
✅Medical writers can work within many types of organisations (as well as freelancing) including:
✅Pharmaceutical and biotechnology companies
✅Pharmaceutical industries
✅CROs
✅Medical communications agencies
✅Government bodies
✅Health insurance companies
✅Medical book publishers
✅News outlets
✅Healthcare providers
Walk-in interviews by Dr. Reddy's labs for production manufacturing and quality control departments at Aurangabad.
✴️Department: Production/ manufacturing
Skills required: Having strong knowledge on operating and maintenance procedures of equipments of compounding/ manufacturing of MDI, DPI, Nasal product and their filling operations.
Experience: 3-7 years
Qualification: Diploma engineering (minimum 60%)
✴️Department: quality control
Experience: 3 to 10 years
Qualification: MSc/ BSc/ B.pharm (minimum 60%)
Skills required:
🔖Knowledge on quality control analysis of finish product and stability of nasal products
🔖Handling of instruments like spray take and spray view HPLC, GC, UPLC, UV spectrometry, FTIR, KARL FISCHER.
Date:13 August 2023 Sunday
Venue: THE AURES HOTEL AND BANQUET padmapura circle, NEAR MITSUBISHI MOTORS, railway station road, Aurangabad, Maharashtra 431005
Job location: Visakhapatnam
Note: candidate should have exposure of working in US-FDA approved organisation
About Organisation:
Kallam anji Reddy Founder of Dr. Reddy's Labs. In 1984 (39 years). In 2014, Dr. Reddy Laboratories was listed among 1200 of India's most trusted brands according to the Brand Trust Report 2014, a study conducted by Trust Research Advisory, a brand analytics company.
Dr. Reddy's pharmaceuticals or labs is multinational company this company manufacturers various Pharmaceutical medicines and APIs. This organisation is Global Innovative pharmaceutical headquartered at Hyderabad.
Dr. Reddy's pharmaceuticals lead manufacturing of generic drug products, diagnostics, vaccine, biologics, over the counter drug products.
Pharmaceutical Products are like nasal drug products, MDI, DPI other liquid syrups tablets, capsules and topical creams, ointments etc. The organisation is innovative having vast variety of manufacturing quality control analytical research and development engineering such department
Dr. Reddy's headquartered at Hyderabad (Telangana) location.
Introduction:
The newly updated guidance published by food and drug administrations current recommendations for optimising and standardizing dietary management in clinical trials for drug products intended treat inborn errors of metabolism when dietary management is important for metabolic control.
The guidance does not address scenarios in which directory optimisation and standard digestion maybe invisible like diseases with prominent neuro psychiatric symptoms.
The updated guidance (July 2023) revises the draft guidance of the same name issued on July 24, 2018 this revision clarified that:
Drug products should be studied in conjunction with dietary management for conditions where dietary management is the current standard of clinical care.
The most informative design is a randomized double-blind clinical trial that includes a concurrent control group (approved drug or Placebo).
Dietary optimization should be based on dietary standards for the relevant population and account for severity of patients metabolic defect and the patients age, growth and general health status.
Background:
Dietary management is an important treatment modality and standard of care for several inborn errors of metabolism where specific in enzymatic defects result in reduced or absent metabolism of a variety of dietary components, with subsequent accommulation of toxic metabolites and organ damage.
Dietary management involves restricting particular food components for example:
🔖Restricting protein for patients diagnosed with urea cycle disorder organic acidemias
🔖Limiting food containing certain fats in patients diagnosed with some fatty acid oxidation defects
🔖Limiting carbohydrates in patients diagnose with certain primary mitochondrial diseases
🔖Removing dietary galactose in patients diagnose with classical galactosemia
🔖Limiting fennel Allen in patients diagnosed with phenylketonuria
Key Recommendations:
👍Some of the key recommendations provided by USFDA
👍Optimising, standardizing and maintaining diet stability in clinical trials.
👍Protocols should specify or standardized approach to dietary management for anticipated intercurrent procedures, illnesses, and metabolic events that may occur during the trial.
👍Considering various aspects of dietary management in Design of clinical trial.
👍Sponsor should encourage families and patients to document there diet frequently during the trial to support the routine documentation obtained during the three days before clinical site visit
For full guidance Visit Click here
Pharma Drug Regulatory Affairs Course-2023
👉Apply Offer link : Click here
Commonly asked Regulatory Affairs Questions and answer click here
Overview of Regulatory affairs
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines, and by the companies.
Job Description: Greeting from Ontop Pharmaceuticals !!!
Important Details :
Packing Supervisor:
Department: Production
Experience: 3 years
Qualification: B.Pharm / B.Sc
Skills: Good knowledge on Primary and Secondary Packing.
2. Blister Machine Operator:
Department: Production
Experience: 3 years
Qualification: ITI
Skills: Hands on experience in Blister Machine operating.
3. Production Trainee:
Qualification: B.Sc / Diploma in Pharmacy
Interested candidates can share cv’s to hrhyd@ontoppharma.com
About Ontop pharmaceuticals:
Believe that quality manufacturing is the result of high intention sincere efforts, skillful execution, intelligent directions. our ultra modern facility at Bangalore is WHO, GMP approved.
There are separate sections and departments for the manufacturing of tablets, capsules, ointments etc.
Manufacturing Plant is based Hyderabad and Bangalore, which is the most nature and friendly places in India.
About Pharma industry in India :
👉Lack of research components and real time good manufacturing practices.
