Amneal Pharmaceuticals, is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our team is working to build one of the most dynamic pharmaceutical companies in our rapidly changing industry. Our leadership and global colleagues are deeply experienced and forward-thinking. We have the capabilities, scale and resources for growth and success. We are nimble and determined. We are Amneal and We make healthy possible.
AMNEAL PHARMACEUTICALS PRIVATE LIMITED – Openings For Injectable Manufacturing & Quality Assurance
We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable unit for our SEZ Matoda Plant.
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 etc.)
Line: Ophthalmic, PFS, Lyo and Vial Line
Positions: (40) Production – Officer/Executive: 15 & Operator: 25
- 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 (IPQA/Validation/EM/QMS/Lab QA) – Injectable unit /Parenteral Unit)
Designation: Officer/Sr. Officer/Executive/Sr. Executive
Qualification: B.Pharm/M. Pharm/ M.sc Microbiology
Total Experience: 02 to 05 years
Vacant Positions: 15
Area: IPQA, Line Clearance, sampling, Environment monitoring, Validation, qualification, protocol preparation, change control, CAPA, Deviation, Vendor qualification, QRM 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.
17. Responsible for Change control, CAPA, Deviation, QRM and Risk Assessment.
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.
You have to walk in for interview with updated CV along with copies of CTC proof, Appointment letter, Increment letter, last 3 months salary slips, Bank statement, Education certificates & Marksheets, Aadhar & PAN card and 1 passport size photograph.
If you are unable to attend interview you can share CV on firstname.lastname@example.org
Below points need to be followed:
- All precautions pertaining to Covid 19 pandemic will be strictly followed.
- Please do not attend interview if you are suffering from any health issue (cold, cough, fever or sore throat). We can conduct a telephonic or video meeting with you later.
- Face Mask is mandatory all the time you are in the premises.
- Social distance will be followed strictly.
- Kindly co-operate with security personnel.
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