Posted: 10 months ago
Posted: 10 months ago
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Job Description
- Ensure bagline production operations comply with all relevant regulatory standards, including cGMP, ISO, and company quality policies.
- Maintain audit readiness for the bagline area and actively support internal and external regulatory inspections.
- Implement and enforce current Good Manufacturing Practices (cGMP) across all bag manufacturing, filling, sealing, and packaging operations.
- Conduct risk assessments for critical bagline processes to identify potential deviations and establish preventive controls.
- Manage process scale-up, validation, and optimization for bag-forming, filling, and sealing operations to ensure robustness and reproducibility.
- Apply QMS tools such as deviation management, change control, and document control for all bagline-related activities.
- Ensure strict compliance with SOPs, batch manufacturing records, equipment logs, and electronic systems used in production.
- Monitor bagline production KPIs (OEE, yield, downtime, rejection rate) and lead continuous improvement initiatives.
- Lead thorough investigations for deviations, bag failures (leakages, seal defects, visual defects), and equipment malfunctions.
- Perform root cause analysis using structured problem-solving tools (5-Why, Fishbone, FMEA) to identify key failure points.
- Develop and implement effective CAPAs to prevent recurrence of quality or operational issues on the bagline.
- Supervise the bagline production team, ensuring compliance with GMP, aseptic behavior, equipment handling standards, and safety protocols.
- Train and mentor team members on bagline operations, GMP compliance, equipment operation, and troubleshooting techniques.
- Foster a culture of discipline, accountability, safety, and continuous improvement within the production area.
- Coordinate with engineering, maintenance, quality assurance, and planning teams to ensure smooth, uninterrupted bagline operations.
Skills
USFDAManpower PlanningParenteralProductionInjectablesPlant OperationsProduction ManagementProduction PlanningRoot Cause AnalysisIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Otsuka Pharmaceutical was established in 1964.
At Otsuka Pharmaceutical, we are committed to a holistic approach to health and well-being of people and are striving to create innovative, thoroughly-original pharmaceutical and nutraceutical products based on our corporate philosophy ""Otsuka-people creating new products for better health worldwide"".
With these two core businesses, analogous to riding on a bicycle, we drive on two wheels.
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