Amneal Pharmaceuticals-(51 Openings) Walk-In Interview for Multiple Positions On 5th June 2022
Job Description
Walk-In Interviews for Injectable Manufacturing & Injectable Quality Assurance
We are looking for Competent, dynamic and motivated candidates for suitable positions for Injectable unit for our Ahmedabad SEZ Matoda Plant.
♦Sterile Manufacturing (Injectable Unit / Parenteral Unit)
Designation: Executive/ Officer/ Operator/ Sr. Officer/ Sr. Executive
Qualification: M.Pharm / B.Pharm / Diploma / B.Sc / ITI/ M.Sc
Total Experience: 02 to 07 years
Area: Aseptic, Controlled area Operation (Sealing, Filling, Bag printing, filtration, intervention, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization, Smoke Study etc).
Line: LYO ,Vial Line, Ophthalmic, PFS
Machine Exposure: Three piece sterile eye drop machine (Groninger), nenomil, isolator, Trucking, Bosch, fedegree & Optima
Positions: 40
Desired Profile:
•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 the quality of the company’s service by means 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 pieces Sterile eye drop filling machine operation (Groninger), Nanomill Operation, autoclave (Fedegari) Manufacturing and Filtration vessel operation, CIP and SIP processing.
♦Quality Assurance (Validation/ IPQA/ EM)- Injectable/ Parenteral Unit
Designation: Executive/ Officer/ Sr. Officer/ Sr. Executive
Qualification: M.Pharm / B.Pharm / M.Sc Microbiologist
Total Experience: 02 to 07 years
Key Area: AIPQA, Line Clearance, BMR-BPR review, Aseptic Area, Media fill, Environment monitoring, Plate settlement, Validation, qualification, Equipment qualification, Process Validation, protocol preparation etc.
Vacant Position: 11
Desired Profile:
- Responsible for preparation, review and implementation of Standard Operating Procedure of Quality Assurance department.
- Should have sound knowledge and experience in Environmental Monitoring (Air Sampling, Settle Plate, Surface Monitoring, Personal Monitoring)
- Responsible for the review of BMR/BPR.
- Responsible for Document management like BMR, BPR, Master Sop, training record etc.
- Responsible for reserve ample management, annual review and destruction as per procedure.
- Responsible for tracking of stability sample collection as per protocol.
- Responsible for stage wise line clearance activity before commencing the operations like dispensing, manufacturing, filling, Lyophilization, sealing, labelling and packing operations.
- Supervision of sampling activity for in-process and finished samples for analysis and other samples requirement as per protocols (Process and finished sample for analysis and other samples requirement as per protocols (Process Validation, Cleaning Validation etc.)
- Responsible to provide and fulfil the documents requirement of Regulatory Affairs department for filing or other requirements.
- This includes documents review, Protocol preparation, qualification executions and support to CFT and report compilation.
- All the equipment qualification (URS, DQ, FAT) i.e. Filling line, Vessels, Packing machines, UAFs, DPBs, Mobile carts, documents review and approval etc.
- 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 Stream, Smoke study, etc.
- Media fills (All process i.e. Liquid, Suspension, Emulsion as applicable)
- Process validation, Cleaning validation, CEHT, DEHT
- Facility qualification, FAT
- 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.
Date: 5th June 2022
Timing: 09:00 AM to 03:00 PM
Venue: Plot No. 15, 16, 17, Pharmez, Village: Matoda, Sarkhej Bavla Road, Ahmedabad 382213
♦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 neha.modi@amnealindia.com
Amneal Pharmaceuticals-(51 Openings) Walk-In Interview for Multiple Positions On 5th June 2022
