QA - Executive (Qualification and Validation)

10 hours ago


Vadodara, Gujarat, India Flagship Biotech International Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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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