Job Description
Job Description
Key Responsibilities:-
Lead batch preparation, compounding, solution preparation activities- Manage qualification & validation: mixing vessel qualification, SIP validation, filtration validation- Ensure correctness of batch records, logbooks, and data integrity compliance- Lead troubleshooting for compounding deviations and filtration failures- Coordinate with QA/Engineering/Warehouse for seamless production
Technical / Functional Skills:- Expertise in compounding systems and solution preparation- Strong qualification & validation experience (IQ/OQ/PQ, CIP/SIP validation)- Knowledge of filter validation, hold time validation, and mixing studies- Strong understanding of formulation, stability, and compounding dynamics
Behavioral Competencies:- Strong leadership and decision-making abilities- Excellent communication and stakeholder management- High compliance and documentation discipline
InjectablesSpecific Expectations:- Experience leading compounding operations for sterile injectables- Understanding of biologic/peptide solution handling- Ability to manage tech transfer & scale-up activities
Qualifications
Experience: 1012 Years (Sterile Injectables)
Qualification: B.Pharm / M.Pharm (Mandatory)
