Chief Quality Assurance Officer

3 days ago

Chennai, Tamil Nadu, India beBeeCompliance Full time US$ 15,00,000 - US$ 20,00,000
Site Leader & Quality Assurance Manager">

Job Purpose:

Our organization seeks an accomplished Site Leader & Quality Assurance Manager to lead and oversee the Quality Assurance function at a manufacturing site. This role will ensure compliance with regulatory requirements, internal quality standards for oral liquids and tablet formulations, and foster a culture of excellence.

Key Responsibilities:

  • Quality Systems Management

    • Implement and maintain robust QMS in line with global regulatory requirements.

    • Oversee deviations, CAPAs, change controls, and risk assessments to minimize quality risks.

    • Review and approve site-specific SOPs, master documents, validation protocols, and reports to ensure quality consistency.

  • Regulatory Compliance

    • Ensure readiness for and manage regulatory audits to maintain a strong compliance record.

    • Lead audit preparation, execution, response, and follow-up activities to address any findings.

    • Maintain data integrity and electronic documentation practices to ensure transparency.

  • Leadership & Team Management

    • Lead and mentor the QA team to foster a culture of compliance, continuous improvement, and collaboration.

    • Develop training plans and oversee periodic training of QA and cross-functional teams to enhance knowledge and skills.

  • Documentation & Records

    • Finalize QA approval for batch release documentation and CoAs to ensure product quality.

    • Oversee document control, archival, and retrieval in compliance with regulatory requirements.

  • Product Quality & Market Support

    • Oversee product quality reviews to identify areas for improvement.

    • Evaluate and support investigation of customer complaints and product recalls to maintain brand reputation.

    • Collaborate with QC, Production, and Regulatory Affairs to ensure quality alignment across functions.

  • Validation & Qualification

    • QA oversight of equipment qualification and process validation to ensure accurate results.

Requirements:

  • Education: Bachelor's or Master's degree in a relevant field, such as pharmacy or science.

  • Experience: Minimum 16 years of experience in pharmaceutical QA, with significant leadership experience in regulated markets.

  • Proven track record of handling regulatory inspections and resolving quality issues.

  • Strong knowledge of regulatory guidelines and data integrity principles to ensure compliance.

  • Exposure to both oral liquids and solid dosage forms is essential for success in this role.

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