Hetero Drugs Recruiting For QA-Manager-Validation .Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.
Eligibility and other details :
- Post Name: QA-Manager-Validation
- Qualification: B.Pharma,M.Pharma with 13-17 Years of Experience
- Location: Hyderabad
- Salary: 13,00,000 – 17,00,000 PA.
- No Vacancies: 01
- Selection Process : Based on Resume Received,will shortlist.
Job description:
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- Responsible for review of Quality Assurance SOPs. Responsible for approval in the absence of Head – QA Responsible for review and approval of other department SOPs. Responsible for preparation, review and updating of master documents like Site Master File, Validation Master Plan & Quality System Manual. Responsible for review and approval of Qualification (Facility, Equipment / Instrument, Utilities & System) / Validation (Process / Cleaning / Stability / Analytical Method etc…) protocols. Responsible for participation in Qualification / Validation activities, evaluation of data and approval of reports. Responsible for verification of compliance and adequacy of technology transfer dossier. Responsible for handling technology transfer activity in coordination with Technology Transfer Department, Transferring Site QA (for site transfer products), Production, QC, Engineering, RA, R&D and AD. Responsible for review and approval of analytical method validation / method verification / method transfer protocols and reports with respect to adequacy. Responsible for review and approval of process characterization protocols and reports.
