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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 QualificationB.Pharm / M.Pharm / B.Sc. / M.Sc.
Experience Level (Years)5 - 7
LocationPunjab
Area of WorkQA
Salary Range (In LPA) -
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