- Overall responsible for all Quality aspects including Control & Assurance.
- Responsible for Developing, implementing, managing, auditing and maintaining the quality management system to international standards. Maintain and control EU cGMP.
- Report on the performance of the quality system, which help decision making for targeted actions.
- Responsible for timely sampling, testing & reporting of all Raw Materials, Intermediates, Finished Products, Packaging Materials, in process samples & Microbiological Analysis of Finished products.
- Responsible for overseeing calibration of Analytical Instruments & Equipments.
- Responsible for overseeing the stability studies as per ICH Guidelines.
- Responsible for AMC scheduling of Analytical Instruments, regular maintenance of QC & Micro dept. premises & equipments.
- Responsible for new recruitment & giving training to all down lines of QC, QA & Micro team.
- Responsible for the preparation of QA related documents such as Vendor questionnaires, audit compliance reports, SOPs, APQR, CAPA, OOS, change control & deviation.
- Responsible for Coordinate and perform all vendor qualification and compliance audits.
- Knowledge of cGMP (Current Good Manufacturing Practice), WHO GMP, ICH-Guidelines & cGLP (Current Good Laboratory Practice).
- Good Knowledge of preparing of SOP's (Standard Operating Procedures), specification & method of analysis of Raw materials, intermediates, packing materials & finished products.
- Responsible for preparation of annual budget & effective cost reduction.
- Knowledge of FDA legal documentation such as technical staff approvals and products approvals.
- Preparation of protocol & report for validation of HVAC, process validation, cleaning validation, analytical validation, microbial validation, clean room validation etc.
- Prepare and filing of Drug Master Files (DMF), Common Technical Documents (CTD) and site master files (SMF) etc.
- Successfully handled audits like cGMP, ISO, HACCP & Important Customer audits of Quality assurance & Quality control, EDQM etc.
Experience of 8-12 years in Quality Assurance/Quality Control Department in Pharmaceutical Bulk Drugs & API plant
- Graduate in any area of life sciences or chemistry.
- Should have comprehensive working knowledge & experience of cGMP (Current Good Manufacturing Practice), WHO GMP, ICH-Guidelines & cGLP (Current Good Laboratory Practice).
- Should approve for Chemical & Instrumental section or Microbiological section from F.D.A. Maharashtra.
- Hands on experience on laboratory Instruments like HPLC, GC, MS, UV Spectrophotometer and etc.
- Knowledge of development of analytical methods
- Ratnagiri, Maharashtra. Conveniently located 3 km from city center and station. If re-location is required, company will provide guest house accommodation till settling down. (Location: https://goo.gl/CkJxnC )