QA - Executive (Qualification and Validation)
10 hours ago
Position :- Sr. Officer / Executive
Department :- QA - Qualification & Validation
Job Location :- Ranu, Vadodara
Experience:- 3-8 years, Regulated MARKET industry.
Role & responsibilities
- Preparation of Validation Master Plan.
- Responsibility for initiation, review and co-ordination for QMS documents such as Change Control, Deviation, CAPA etc.
- Preparation and review of SOP related to startup of new facility.
- Preparation and review of Qualification documents i.e. URS, FS, DQ, FAT, SAT, IQ, OQ & PQ.
- Coordination with other cross functional team for the execution of validation projects.
- On-site execution of validation protocols, report generation and participating in on-site qualification or commissioning activities
Preferred candidate profile
- B. Pharm/ M. Pharm Candidate
- Experience in Qualification & Validation within regulated MARKET industry.
- Good knowledge of GMP, ISO standards, regulatory requirements (e.g., USFDA, EU, EMA) relevant to qualification/validation.
- Strong understanding of qualification lifecycle (IQ/OQ/PQ), process validation, Cleaning Validation and computerized system validation (CSV) is an advantag
- Proficient in documentation: writing protocols, reports, technical documents, deviations, CAPAs.
Interested candidate can apply on or can call on
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