QA - Executive (Qualification and Validation)

Flagship Biotech International

3 - 8 years

3 - 8 Lacs

vadodara

Posted:2 weeks ago| Platform:

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Skills Required

capa change control validation life cycle sterile injectable products oq & pq greenfield projects sat iq fs dq computer system validation urs fat qms documents deviation

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 hr1@flagshipbiotech.com or can call on (+91) 22 40659 261.

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