Rubicon Research Jobs – Production documentation Experts
Rubicon looking for a Production documentation Experts who has hands on experience on BMR, BPR, PVR, PVP, APQR Preparation in Pharma industry.
Job Description
- Preparation of master batch manufacturing records & Batch Packing Records
- Handling of Quality Management System (QMS) related activities of the section i.e. Change Control, Incident, Deviation, Corrective & preventive Action (CAPA).
- Preparation of Process/Packing evaluation Protocols & Reports.
- Preparation of Process/Packing Validation Protocols & Reports.
- Communication with RA, PMI and TT team for assessment batches, commercial launch to regulatory markets.
- Prepare the risk assessments, GAP analysis, MMF, trends for MBMR preparation yield
- To understand & implement properly the concept of Man, Material, Machine & Methods to ensure a quality product.
- Process monitoring (dispensing, granulation, compression, coating, encapsulation, FBP coating, bottle / blister packing) for validation batches.
- To finalize process parameters for intended / commercial batches. 10. To determine batch size for scale up, exhibit and commercial batches.
Experience : 5-8 Years.
Education : B Pharmacy / M Pharm / BSc / MSc
CTC-Best as per Market standards
Location-Ambernath (Near Mumbai)
Application Process : Interested candidates please share your Resume on [email protected]
