Quality Assurance Manager

Job Description

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• GMP Compliance – Drug Product Facility
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• Monitor day-to-day activities and plan allocation of IPQA personnel as per batch schedule. Oversee critical manufacturing activities including dispensing, in-process checks, sampling, filling, sealing, visual inspection, and AQL.
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• Coordinate with Drug Product (DP) teams for smooth batch execution from dispensing to dispatch.
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• Review technical documents related to drug product manufacturing.
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• Media Fill, Validation, and Qualification
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• Review media fill protocols and reports in compliance with current regulatory guidelines. Ensure equipment and area qualifications, including periodic requalification for drug product facilities.
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• Review process validation and cleaning validation protocols and reports.
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• Ensure availability of visual inspection qualification kits.
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• Contract Manufacturing Organizations (CMOs) Activities
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• Ensure manufacturing and analytical activities at CMOs are conducted in compliance with Quality Technical Agreements and cGMP requirements.
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• Coordinate and communicate with CMO manufacturing and analytical teams for timely execution and tracking of activities.
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• Identify the need for new procedures and ensure their implementation; perform gap analysis of existing procedures.
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• Review executed Batch Processing Records (BPR) and Analytical Records (AR) for batch release, and coordinate with CMOs to ensure compliance.
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• Review and approve Annual Product Quality Review (APQR) reports for products manufactured at CMOs.
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• Market Complaint and Recall Activities
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• Manage market complaints including registration, communication with complainants and DSRM, investigation, and implementation of corrective and preventive actions (CAPA).
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• Notify stakeholders regarding product or batch recalls/market withdrawals
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