We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable unit for our Ahmedabad SEZ Matoda Plant.
Date: 05-Jun-22 (Sunday)
Time: 9:00 am to 3:00 pm
Department: Injectable Manufacturing & Injectable Quality Assurance
Venue for Interview: Amneal Pharmaceuticals Pvt. Ltd. Plot No 15,16,17 Pharmez, Sarkhej Bavla Highway, Vil. Matoda, Ahmedabad 382213
1. Sterile Manufacturing (Injectable/Parenteral Unit)
- Designation: Operator/Officer/ Sr. Officer /Executive/ Sr. Executive
- Qualification: ITI/ B.Sc/ Diploma / B. Pharm / M.Sc/ M. Pharm
- Total Experience: 02 to 07 years
- Area: Aseptic & Controlled area operation (Filling, Sealing, filtration, intervention, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization, smoke study etc.)
- Line: Ophthalmic, PFS, Lyo and Vial
- Machine Exposure: Three piece sterile eye drop machine (Groninger), nenomil, isolator, Trucking, Bosch, fedegree & Optima
- Open Position: 10 Officer & 30 Officer
- To observe & follow all rules and regulations of the production department.
- Must be from Parenteral background & exposure to filling process is desirable.
- To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures.
- Sound technical knowledge of Aseptic area & Controlled area related activities.
- Technical exposure and expertise on filling & Autoclave machine.
- Knowledge of Regulatory guidelines and exposure of USFDA audits.
- Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing area of injectable.
- Expertise in batch manufacturing and preparation related activities.
- Knowledge of equipment validation and qualifications in injectable.
- Preparation & review of BMR-BPR
- Preferred Exposure for Ophthalmic line: Three piece sterile eye drop filling machine operation (Groninger), Nanomill Operation, autoclave (Fedegari) Manufacturing and Filtration vessel operation, CIP and SIP processing
2. Quality Assurance (Validation/IPQA/EM) – Injectable/Parenteral Unit)
- Designation: Officer/Sr. Officer/ Executive/ Sr. Executive
- Qualification: B.Pharm/M. Pharm/ M.sc Microbiologist
- Total Experience: 02 to 07 years
- Vacant Positions: 11
- Key area: IPQA, Line Clearance, BMR-BPR review, Aseptic area, Media fill, Environment monitoring, Plate settlement, Validation, qualification, Equipment qualification, Process validation, protocol preparation, etc.
1. Responsible for preparation, review and implementation of Standard Operating Procedures of Quality Assurance department.
2. Should have sound knowledge and experience in Environmental Monitoring (Air Sampling, Settle Plate, Surface Monitoring, Personnel Monitoring)
3. Responsible for the review of BMR/BPR.
4. Responsible for Document management like BMR, BPR, Master SOP, training record etc.
5. Responsible for reserve sample management, annual review and destruction as per procedure.
6. Responsible for tracking of stability sample collection as per protocol.
7. Responsible for stage wise line clearance activity before commencing the operations like dispensing, manufacturing, filling, Lyophilization, sealing, labelling and packing operations.
8. Supervision of sampling activity for in-process and finished samples for analysis and other samples requirement as per protocols (Process Validation, Cleaning Validation etc.)
9. Responsible to provide and fulfil the documents requirement of Regulatory Affairs department for filing or other requirements.
10. This includes documents review, protocol preparation, qualification executions and support to CFT and report compilation.
11. All the equipment qualification (URS, DQ, FAT) i.e. Filling line, Vessels, Packing machines, UAFs, DPBs, Mobile carts, documents review and approval etc.
12. All the utility qualification (URS, DQ, FAT, IQ, OQ, PQ) i.e. HVAC, Compressed air, Nitrogen gas, WFI (Phase I, Phase II, Phase III), PW (Phase I, Phase II, Phase III), Pure Steam, Smoke study, etc.
13. Media fills (All process i.e. Liquid, Suspension, Emulsion as applicable)
14. Process validation, cleaning validation, CEHT, DEHT
15. Facility qualification, FAT
16. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP/ GLP and understanding of regulatory requirement will be preferred.
Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization.
Interested candidates can share resume on [email protected]