Team Leader

• Formulation R&D Documentation

• Prepare and maintain:

  • Batch Manufacturing Records (BMRs)

  • Batch Packaging Records (BPRs)

  • Product Development Reports (PDRs)

  • Technology Transfer documents

  • Development protocols and reports

• Ensure timely and accurate documentation of formulation trials, observations, and outcomes.

• Assist formulation scientists in preparing regulatory and technical documents.

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    Cross-functional Coordination

  • Liaise with QA, Regulatory Affairs, and Manufacturing Technology Transfer teams for timely documentation support.

  • Track project documentation timelines and ensure timely delivery of required documents.

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     Documentation & Records Management

  • Maintain indexing and archival of all R&D documents for easy retrieval and compliance.

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    • Participate in internal and external audits and inspections by providing required documentation.

    • Maintain strict version control and ensure document traceability.

    Regulatory and Quality Compliance

  • Ensure all R&D documentation adheres to GMP, GLP, ICH, and regulatory requirements.

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    Analytical R&D Documentation

  • Prepare and maintain:

    • Method development & validation protocols/reports

    • Analytical method transfer documents

    • Stability protocols and reports

    • Instrument calibration & maintenance logs

    • Raw data compilation and summaries

  • Support analysts with proper documentation practices and adherence to data integrity requirements.

M. Pharmacy or MSC candidate good documentation as well as communication skill.