Qa Executive(QMS)

Stellar Formulations

5 - 8 years

2 - 5 Lacs

savli vadodara

Posted:3 weeks ago| Platform:

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Skills Required

apqr capa qms mfr validation protocols/report risk assessment bpr bmr smf change control oos sop vmp analytical reports vendor qualification

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities:

Preparation and Review of documents such as SOP, BMR, BPR, Analytical Reports, SMF, VMP, APQR, MFR validation protocols/report and qualification protocols/report.
To maintain, destruction records and ensure safe destruction of obsolete records.
Execution and evaluation of qualification and validation studies.
Participation in technology transfer process from F & D and other manufacturing site.
To review the change control proposed and to ensure closure of the change controls, post implementation after conducting impact assessment.
Investigate deviations, non-conformances, and out-of-specification (OOS) results.
Implement and track Corrective and Preventive Actions (CAPA).
Vendor qualification
Risk assessment
To support preparations at site for external audits. Help in preparation of compliance reports.
Allocate the responsibility to the IPQA team for the shift operations if applicable
Work closely with production, QC, R&D, and other departments to resolve quality issues for GMP compliance.

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