We have an urgent requirement for QA Documentation below position at Extrovis Pharmaceuticals 

Department: QA (Formulations)

Experience: 2-8 yrs

Salary: Industry Standards

Positions: 04

Location: Hyderabad.

Key Skills:

Documents review related to Product (Formulation, Analytical, Process, Packaging & Deficiency response). Review of documents related to Analytical (Method Development, Method Validation, Stability, PDR, Method Transfer, specifications, test methods, protocols, reports). 

Review of Qualification documents of laboratory working standards, instruments, Equipment's and maintenance of records as per schedule.

Dealing with cross functional teams and external foreign partners for project development and submission for regulated markets. 

purpose Involving and resolving the issues related to OOT, OOS, CAPA & Quality Notifications with internal and external manufacturing partners.

Ensuring compliance through Quality Management System (ELN, Change control, SAP etc.,).

Conducting internal and External audits with CRO's, CMO's and CTL. Having exposure in US-FDA, MHRA audits.

Conducting Stage meetings at the Development, Pilot bio, Exhibit and Filing stage.

Preparation of SOP's related to System, Process & Quality. 

Scheduling training to all the New employees regarding Documentation, compliance and Quality system.

Please send your resumes at hr@extrovis.com