Job
Description
JOB OPENING FOR API API MANUFACTURING 1. Role: Sterile- Autoclave, Compounding, Crystallization & Filling Experience: 5 to 12 years Education: B. Sc/M.Sc Chemistry/B.Pharm/M. Pharm Job Description: 1. Handling of Autoclave, DHS, Canister washing machine, Crystallizer, ANFD, Co-mill, Sterile batch mixture and filling machine. 2. Well versed knowledge of sterile process and Media fill, filter integrity machine, NVPC Machine 2. Role: Sterile- Shift Incharge Experience: 6 to 12 years Education: B. Sc/M.Sc Chemistry/B.Pharm/M. Pharm Job Description: 1. Well versed knowledge in Validation, Qualification, Media Fill, SAP activity, change control, Deviations, CAPA, Investigations and other QMS related activities, Filter intrigity Machine, NVPC Machine. 2. Exposure in Regulatory inspection audits 3. Role: Non-Sterile Experience: 2 to 8 years Education: B.Sc/M.Sc(Chemistry)/B E/B.Tech(Chemical) Job Description: 1. Handling of Hydrogenation reaction. 2. Handling all type of equipments.. Reactor, Sparkler Filter, Centrifuge, VTD, FBD, etc 4. Role: Non-Sterile (Shift Incharge) Experience: 5 to 10 years Education: B.Sc/M.Sc(Chemistry)/B E/B.Tech(Chemical) Job Description: 1. Well versed knowledge in Validation, Qualification, Media Fill, SAP activity, change control, Deviations, CAPA, Investigations and other QMS related activities. 2. Knowledge of Clean room. 5. Role: Documentation Experience: 5 to 10 years Education: B.Sc/M.Sc(Chemistry)/B E/B.Tech(Chemical) Job Description: 1. Well versed knowledge of change control, Deviations, Investigation, QMS and cGMP. 2. Preparation and revision of MFR or MPR, BMR or BPR, SOPs, Trend, Qualification, Validation related documents, Protocol and reports 4. Well versed knowledge of SAP system. API WAREHOUSE 1. Experience: 5 to 8 years Education: B.Sc/M.Sc(Chemistry)/B E/B.Tech(Chemical) Job Description: 1. Oversee the receiving, storage, and distribution of raw materials, packaging materials, intermediates, and finished products. 2. Well knowledge in SAP activity 2. Experience: 6 to 10 years Education: B.Sc/M.Sc(Chemistry)/B E/B.Tech(Chemical) Job Description: 1. Coordinate with procurement, production, and logistics teams to ensure timely and accurate delivery of materials. 2. Knowledge in SAP activity. 3. Activities comply with GMP, GDP and other regulatory requirements. API QA 1. QMS Experience: 4 to 7 years Education: M.Sc(Analytical Chemistry)/M.Pharma Job Description: 1. Preparation of SOP, Specification, STP, ARDS, Protocol, Reports, Stability summary report, Miscellaneous document and analytical method validation inline of applicable pharmacopoeia and ICH guideline. 2. Handling of QMS related activity i.e OOS, OOT, Deviation, OOC, Change control and CAPA 2. Validation Experience: 2 to 5 years Education: M.Sc(Analytical Chemistry)/M.Pharma Job Description: 1. Knowledge of preparation, review & compilation of qualification and validation documents. 2. Handling and preparation of regulatory audits 3. To prepare and review Computer System Validation Master Plan document. 3. IPQA Experience: 2 to 5 years Education: M.Sc(Analytical Chemistry)/M.Pharma Job Description: 1. Monitor, assess, and validate ongoing manufacturing processes, ensuring compliance with regulatory requirements, internal SOPs, and GMP. 2. Perform investigation and resolution of any quality issues and document any process deviations and implement corrective action.
