What are the responsibilities and job description for the Regulatory Document Control Specialist position at Evergreen Theragnostics?
Job Title: Master Batch Record Compliance Expert
Job Summary: Evergreen Theragnostics is seeking a highly skilled Master Batch Record Compliance Expert to join our team. The successful candidate will be responsible for ensuring the accuracy, compliance, and completeness of Master Batch Records (MBRs) in pharmaceutical manufacturing.
Key Responsibilities:
- Review and validate MBRs to ensure accuracy, completeness, and compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure that all documentation reflects proper procedures and standards.
- Develop and maintain 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.
Requirements:
- Minimum 2-3 years of experience in quality assurance, batch record review, or a related role in pharmaceutical or biopharmaceutical manufacturing.
- Strong knowledge of GMP, FDA regulations, and other relevant regulatory guidelines.
- Excellent communication and leadership skills.
