What are the responsibilities and job description for the Batch Record Compliance Specialist position at Evergreen Theragnostics?
Job Description
The Quality Assurance (QA) Master Batch Record Reviewer plays a crucial role in ensuring the accuracy, compliance, and completeness of Master Batch Records (MBRs) in pharmaceutical manufacturing. This position is vital in maintaining the highest standards of quality, regulatory compliance, and Good Manufacturing Practices (GMP) throughout the production process.
Key Responsibilities
- Conduct thorough reviews of MBRs for accuracy, completeness, and compliance with regulatory requirements, GMP guidelines, and company Standard Operating Procedures (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 SOPs related to batch record review.
- Provide feedback and guidance to production and quality control teams regarding documentation errors and corrections needed for compliance.
- Maintain organized records of batch reviews and approvals, ensuring timely and accurate filing of completed MBRs.
- Support the implementation of continuous improvements in batch record processes and documentation practices.
