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Senior Executive QA
Pharmaceuticals
Punjab
5 yrs exp
Job Description
Key Responsibilities
Prepare, review,
revise
and control QA documentation
in accordance with
cGMP and applicable regulatory requirements.
Review Batch Manufacturing Records, Batch Packing Records, logbooks and other production and quality documents.
Independently handle deviations, incidents, CAPA, change controls,
investigations
and root-cause analysis.
Prepare and review SOPs, protocols, reports,
formats
and quality-system documents.
Monitor API manufacturing activities and ensure shop-floor compliance with approved procedures.
Ensure effective document issuance, distribution, retrieval, archival, version control and record retention.
Review equipment qualification, process validation, cleaning validation,
calibration
and preventive-maintenance records.
Ensure compliance with data-integrity requirements and ALCOA+ principles.
Participate in internal, customer and regulatory audits and ensure
timely
closure of audit observations.
Conduct cGMP and SOP training and
maintain
the related records.
Coordinate with Production, QC, Warehouse,
Engineering
and other departments on quality-related activities.
Guide junior QA team members and ensure
timely
completion of assigned quality-system activities.
Candidate Profile
Must have 5–7 years of QA experience in an API manufacturing facility.
Strong knowledge of cGMP documentation and pharmaceutical quality systems.
Hands-on experience with batch-record review, deviations, CAPA, change controls and investigations.
Good understanding of relevant guidelines such as ICH, WHO-GMP, USFDA or EU-GMP.
Strong documentation, audit-handling,
communication
and team-coordination skills.
Minimum Qualification
B.Pharm / M.Pharm / B.Sc. / M.Sc.
Experience Level (Years)
5 - 7
Location
Punjab
Area of Work
QA
Salary Range (In LPA)
-
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