Sr. Officer, Production & Process Compliance – India
Company: Herbalife International India Pvt. Ltd.
About the Job
Position Summary:
The Sr. Officer, Process Compliance – Manufacturing is tasked with ensuring compliance with current Good Manufacturing Practices (cGMP) and Good Storage Practices (GSP) across contract manufacturing sites. This role is crucial in maintaining the sustainability of various checks, controls, and Corrective and Preventive Actions (CAPA) implemented in the manufacturing processes. The Sr. Officer will also provide essential training to Contract Manufacturing (CM) staff, manage and facilitate investigations, ensure the effectiveness of CAPA implementations, and monitor the progress of open investigations.
Key Responsibilities:
- cGMP and GSP Compliance: Ensure compliance at CM sites through regular monitoring of shop floor activities and conducting GMP rounds across manufacturing and service areas.
- Manufacturing & Packaging Oversight: Review and verify manufacturing and packaging activities to ensure they meet Herbalife’s requirements. This includes verification of in-process parameters for powder manufacturing, granulation, compression, coating, capsule filling, counter filling (tablet & capsule), and stick packing.
- Troubleshooting Support: Provide support to CMs during manufacturing and packaging activities by assisting with troubleshooting.
- Batch Documentation: Design, draft, and review batch documents to ensure accuracy and compliance.
- Investigation Management: Manage, document, and review investigations to identify root causes and ensure the implementation and effectiveness of CAPA.
- Non-Conformance Handling: Conduct investigations for non-conformances with CMs and Herbalife cross-functional teams to identify root causes and implement CAPA.
- CAPA Effectiveness: Monitor the effectiveness of implemented CAPAs and ensure timely closure of open investigations and action items.
- Daily Observations Compilation: Compile daily observations from the shop floor and track the implementation of CAPA.
- Routine Updates: Provide regular updates on the status of manufacturing investigations to project teams and clients, managing client involvement as needed.
- Visual Management: Drive visual management processes to track the progress of open investigations, ensuring that timelines are met and escalated when necessary.
- Cross-Functional Support: Organize and delegate responsibilities across various functions to support investigations.
- Training & OpEx Support: Support the OpEx team by providing training to CM teams, verifying closed action items, and ensuring the sustainability of implemented actions.
Minimum Qualifications:
- Education: Graduate in Food Technology, M.Pharmacy, Nutrition Science, Mechanical Engineering with Food industry experience.
- Experience: Minimum 3-5 years in the Pharma/Nutraceutical/Food industry with experience in Quality Assurance or Manufacturing roles.
- Skills:
- Result-oriented with the ability to lead shop floor teams.
- Proficient in Microsoft Office (Word, PowerPoint, Excel).
- Excellent communication skills, both written and verbal.
Industry Type: Pharma/Nutraceutical/Food
Experience: Quality Assurance, Manufacturing
Sr. Officer, Production & Process Compliance – India
How to Apply:
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