Manufacturing Excellence Specialist
8 hours ago
This role is responsible for ensuring the highest standards of quality in sterile injectable production. It requires a meticulous approach, thorough examination of batch records, and collaboration with teams to resolve discrepancies.
The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques, as well as expertise in validation methodologies and regulatory guidelines.
Key Responsibilities:- Batch Review: Examine executed batch manufacturing records (BMRs) and batch packaging records (BPRs) for completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
- Discrepancy Resolution: Collaborate with on-site teams to resolve discrepancies or missing documentation before batch release.
- Data Analysis: Review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results to ensure product quality.
- Label Verification: Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.
- APQR Reporting: Compile, review, and analyze electronic data for Annual Product Quality Review (APQR) reports, identifying trends or recurring issues.
- Change Control: Review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance.
- Deviation Management: Conduct remote review of deviation reports, root cause analyses, and corrective action proposals, tracking deviation trends for periodic reporting.
- CAPA Planning: Approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria.
- Education: Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
- Skills: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques, expertise in validation methodologies and regulatory guidelines, strong analytical and problem-solving skills, effective communication and documentation skills, ability to manage cross-functional teams and prioritize tasks.
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