Qualification & Experience
M.Pharm / M.S / B.S in Chemistry, Pharmaceutics or related discipline
3–5 years of experience in R&D; (DQA)
Solid knowledge of GMP, GCP, GLP and 21 CFR 210/211
Experience with dermatology products or medical devices is an advantage
Key Responsibilities
Review development documents, analytical methods, R&D; trials, lab notes, PDR, MFR, and batch records
Maintain R&D; documentation and activities as per cGMP and GDP
Develop, implement and manage QMS elements (SOPs, Change Control, Deviations, CAPA, Complaints, etc.)
Support equipment qualification (DQ, IQ, OQ, PQ)
Tech transfer from R&D; to pilot and production, including scale-up and optimization
Coordinate with R&D; and Plant for batch execution and documentation
Responsible for process scale up & Optimization studies from R&D; to Pilot and then to production scale.