Qa Executive

• Preparation, review and distribution of standard operating procedures and Record maintenance.
• Co-ordination with cross functional teams to execute the SOP, validation protocol and report, cleaning activities and batch release.
• Preparation of Batch Manufacturing Record, review, issuance, retrieval and maintenance.
• Preparation and review of Validation/Qualification protocols and reports for the process, cleaning, equipment like Reactors, Centrifuges, Fermenters, Dryers, Sifters etc.
• Preparation, review, issuance, retrieval of Specifications, Standard Testing Procedures, Analytical Raw Data Sheets and etc.,
• Analytical QA and Ensure that Quality Control and other cross functional team systems are functioning.
• Preparation and review of Material Safety Data Sheet.
• Monthly GMP inspection and Glass brittle wood materials inspection and record maintenance.
• Preparation of dispatch related documents for sample and commercial dispatch Sample dispatch activity, Commercial dispatch activity.
• Label preparation and Label control for all products.
• Preparation and Review of Annual product quality review (APQR).
• Issuance of forms, formats and log books for all the cross functional teams.
• Preparation, participation and compliance for audits such as ISO 9001:2015, BRC, GMP, ICH Q7, 21CFR 210& 211, ISO 17025 (NABL), EDQM/EMA, WHO, Halal, Kosher and customer audits.
• Preparation of internal audit schedule and coordinating with internal audit team.
• Handling of mater data management.
• In-process QA activities and line clearance.
• Review of certificate of analysis.
• Preparation of Quality Agreements and vendor Evaluations.
• Initiation, review and implementation of change control, deviation, market complaints, OOS, OOT and etc.,
• Coordinating for regulatory activities for compilation of DMF, CTD and extending the support for the responding regulatory Queries.
• Supporting for vendor qualification of Key starting materials/intermediates to use in API/Biopharmaceutical industry.

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