POSITION SUMMARY
The Process Compliance Sr. Officer, Manufacturing ensures compliance with cGMP & GSP and sustainability of checks and controls at contract manufacturing sites. This role includes training CM staff, managing investigations, and providing routine status updates.
Sr. Officer, Process Compliance - Manufacturing
- Ensure cGMP and GSP compliance at CM sites.
- Monitor shop floor activities, including GMP rounds and verification of manufacturing and packaging processes.
- Support CMs with troubleshooting and document batch processes.
- Manage and review investigations to identify root causes and implement effective CAPA.
- Track open investigations and ensure timely closure.
- Compile daily observations and provide routine updates on manufacturing investigations.
- Drive visual management to track progress and meet timelines.
- Organize cross-functional resources for investigations and delegate responsibilities.
- Support OpEx team with training and verification of action items.
MINIMUM QUALIFICATIONS
Education: Graduate in Food Technology, M.Pharmacy, Nutrition Science, or Mechanical with Food industry experience.
Skills:
- Result-oriented and team player.
- Leadership skills for shop floor teams.
- Proficient in Microsoft Office (Word, PowerPoint, Excel).
- Good communication skills, both written and verbal.
Experience:
- 3-5 years in Pharma/Nutraceutical/Food industry.
- Experience in QA/Manufacturing functions.