Job Description

Job Description – Quality Assurance Specialist, Batch Record Reviewer

Summary: Reporting to Quality Assurance Manager. The Quality Assurance (QA) Master Batch Record Reviewer is responsible for ensuring the accuracy, compliance, and completeness of Master Batch Records (MBRs) in pharmaceutical manufacturing. This role is crucial in maintaining the highest standards of quality, regulatory compliance, and Good Manufacturing Practices (GMP) throughout the production process. The reviewer collaborates with cross-functional teams, including production, quality control, and regulatory affairs, to ensure that all documentation reflects proper procedures and standards, ensuring the safety and efficacy of pharmaceutical products.

Responsibilities:

• Conduct thorough reviews of MBRs for accuracy, completeness, and compliance with regulatory requirements, GMP guidelines, and company SOPs.
• Verify that all documentation (e.g., raw material records, manufacturing steps, in-process checks, and test results) is properly recorded and traceable.
• Ensure all deviations, discrepancies, and non-conformances are documented and resolved before batch release.
• Work with the QA team to prepare for audits and inspections by regulatory bodies.
• Assist in the development and maintenance of standard operating procedures (SOPs) related to batch record review.
• Provide feedback and guidance to production and quality control teams regarding documentation errors and corrections needed for compliance.
• Support the implementation of continuous improvements in batch record processes and documentation practices.
• Maintain organized records of batch reviews and approvals, ensuring timely and accurate filing of completed MBRs.
• Assist in the revision and approval of new or modified MBR templates as needed.

Essential Education and Qualifications:

• Strong knowledge of GMP, FDA regulations, and other relevant regulatory guidelines (e.g., ICH, ISO, EMA).
• Excellent attention to detail, organizational, computational and communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficient in using quality management systems (QMS) and document control software.
• Strong communicator with good leadership abilities, capable of providing guidance to production and quality control teams regarding documentation errors and corrections needed for compliance

Experience required – in years

• Minimum 2-3 years of experience in quality assurance, batch record review, or a related role in pharmaceutical or biopharmaceutical manufacturing.

Education required and/or preferred

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field; advanced degree preferred.

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