
Executive - Production QMS
4 weeks ago
Role & responsibilities
Execute daily production operations and ensure the efficient functioning of the department.
- Supervise and monitor manufacturing processes to ensure compliance with quality standards.
- Review and maintain production-related QMS elements, including Change Control, Deviation, Event Investigation, and Corrective and Preventive Actions (CAPA).
- Prepare and review Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), and Batch Packing Records (BPRs).
- Address and resolve production issues promptly to minimize downtime and ensure continuous production.
- Respond to challenges or bottlenecks and implement mitigation strategies within defined timelines.
- Ensure that all processes and documentation comply with SOPs and protocols.
- Maintain and review all production-related records, including batch records, equipment logs, and production output reports.
- Prepare regular reports on production output, efficiency, and quality metrics for management review.
- Coordinate with the maintenance department to resolve equipment breakdowns and ensure smooth production activities.
- Oversee the document control system to ensure the availability and integrity of quality documents.
Preferred candidate profile
- Bachelor's or Masters degree in Pharmacy, Life Sciences, Biotechnology, or a related field.
- Minimum of 1 year of experience in a production/QMS-related role within the pharmaceutical, biotechnology, or manufacturing industry.
- Strong understanding of QMS principles, regulatory compliance, and production processes.
- Ability to analyze and resolve production-related challenges effectively.
- Proficiency in documentation, report preparation, and adherence to SOPs.
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