- To ensure that released starting materials, trial materials and bulk and finished oral solid dosage (OSD) products (as well as all associated documentation) comply with GMP guidelines, regulatory and in-house requirements
- Exercise pharmaceutical responsibility for product release for use into the marketplace
- To ensure new launch requirements are met
- Translates priorities list from Production Planning into work schedule to ensure that market demands are met
- Compile and maintain departmental operating procedures and standard forms
- Maintain Bill of Materials, Item Master and Lot Masters in BAAN
- Develop master batch records (BMI’s, BMR’s, BPR’s) in compliance with the dossier and GMP requirements
- Train relevant personnel on batch documentation
- Recommend and implement improvements to documentation
- Approve and unblock raw materials and components (In conjunction with the laboratories)
- GMP audit of all bulk and finished product documentation and final release approval for sale
- Control of disposition batch records, retention samples and lot documents
- Assist with departmental training
- Qualified Pharmacist registered with the SA Pharmacy Council.
- At least 1 year experience in the Pharmaceutical Industry, preferably in OSD Manufacturing Facility.
- Clear understanding of Pharmaceutical requirements and a good working knowledge of GMP.
- Computer literate – Word, Excel, QUMAS, Process Compliance
- Baan knowledge is advantageous
Pharmaceutical And Medical/Healthcare