Job Description
Job Description
Key Responsibilities:-
Supervise weighing, dispensing, solution preparation, pH/osmolality adjustment, and mixing as per BMR- Plan and execute sterile filtration with pre- and post- integrity testing; maintain filter traceability- Oversee CIP/SIP of compounding vessels, hold tanks, and transfer lines; verify readiness for use- Manage aseptic transfers to filling area; ensure closed transfers/single-use systems where applicable- Perform yield calculations, reconciliation, and ensure adherence to material and yield tolerances- Monitor critical parameters (temperature, mixing speed, time) and document IPC results- Coordinate with QA/Engineering/Warehouse to secure timely materials and equipment availability- Review BMR/logbooks, ensure ALCOA-compliant entries; support deviations, CAPA, and change controls- Train/mentor operators on solution prep, filtration, and safe handling of potent/biologic materials- Drive improvements in right-first-time batches, hold-time compliance, and line changeover time
Technical / Functional Skills:- Hands-on with compounding systems, jacketed tanks, magnetic mixers, and transfer pumps- Expertise in CIP/SIP, steam quality basics, condensate management, and sterile connections- Filter selection (PES/PVDF), sizing, wetting agents, and integrity test methods (bubble point, diffusion)- Understanding of solution stability (temperature/shear/light), and mixing dynamics- Experience with biologic/peptide compounding (cold chain handling, shear sensitivity)- Strong grasp of cGMP, Annex 1, US FDA expectations, and data integrity (ALCOA+)
Behavioral Competencies:- Ownership, discipline, and a strong compliance mindset- Ethical behavior, honesty, and accuracy in documentation- Clear communication and cross-functional coordination- Ability to coach operators/technicians and manage shifts- Structured problem-solving and calm decision-making on the floor
InjectablesSpecific Expectations:- Proven experience in injectable compounding and sterile filtration- Knowledge of aseptic transfers and contamination control in compounding rooms- Ability to manage batch scale-ups and tech transfers with PQ support
Qualifications
Experience: 35 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm
