Amneal Pharma Quality Walk-in
- Amneal Pharmaceuticals
- 2 - 7 years
- Ahmedabad
- 4 years ago
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Job Description
We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable unit for our Ahmedabad SEZ Matoda Plant.
1. Quality Assurance (IPQA/Validation/EM/QMS) - Injectable unit /Parenteral Unit)
Designation: Officer/Sr. Officer/ Executive
Qualification: B.Pharm/M. Pharm/ M.sc Microbiologist
Total Experience: 02 to 07 years
Vacant Positions: 12
JD: IPQA, Line Clearance, Environment monitoring, Validation, qualification, Quality Management System, Change control, Deviation, CAPA, 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 stage wise line clearance activity before commencing the operations like dispensing, manufacturing, filling, Lyophilization, sealing, labelling and packing operations.
4. Supervision of sampling activity for in process and finished samples for analysis and other samples requirement as per protocols (Process Validation, Cleaning Validation etc.)
5. To review test results comparison report of API/ Excipients against manufacturer's certificate of analysis and Amneal's certificate of analysis for vendor qualification.
6. Review and implementation of vendor notification/declaration provided by SSSM from respective vendor at site.
7. To prepare standard operating procedures of Quality Assurance Department and review the SOPs of cross functional departments.
8. To handle the changes carried out in the location by assessing the risks associated with it as per the change control procedure.
9. Supervision of sampling activity for in process and finished samples for analysis and other samples requirement as per protocols (Process Validation, Cleaning Validation etc.)
2. Quality Control - (Injectable unit /Parenteral Unit)
Designation: Officer/Sr. Officer/Executive
Qualification: M.sc/ B.pharm/ M.pharm
Total experience: 02 to 07 years
Positions: 20
Area: GLP, Calibration, HPLC, QC-QMS, LIMS, Stability, RM, PM, FP, IP, Stability, Analysis, Testing, reviewer etc.
1. Testing of raw material, packing material, in-process, finished product and stability samples (as per stability protocol).
2. To keep neat and cleanliness at work place and follow the Good laboratory practices in the laboratory.
3. To keep update of instrument slog-books and to record the data in LNB during testing. To attain and complete self-training record.
4. To initiate and review of A)Deviation B)Out of specification/Out of trend C)Change control
5. To ensure in and out of stability samples from stability chambers.
6. Charging of stability samples as per stability protocol.
7. To perform water analysis as per specification, SOP and GTP.
8. To co-ordinate QA for documentation for issuance and retrievals.
9. Review and monitoring of USP, EP, BP and other pharmacopeia monographs for changes/ revision.
10. To prepare COA of various product/material as per requirement whenever required.
11. LIMS master preparation for various product / material/ instruments/ Volumetric solutions etc.
12. Registration of reference standard, working standard, column, instrument etc. in LIMS
13. Preparation/updating of calibration schedule in LIMS
14. Updating of LIMS master as and when required
15. Preparation of configured Test plan.
16. Trouble shooting in LIMS, Involve in Qualification of LIMS module/ Instrument, Preparation of LIMS related protocol study and execution.
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 ne******i@am********a.com
Below things need to follow:
- 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.
Job Classification
Industry: Pharma, Biotech, Clinical ResearchFunctional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Medical Professional
Role: Medical Professional
Employement Type: Walk-ins
Education
Under Graduation: B.Pharma in PharmacyPost Graduation: M.Pharma in Pharmacy, MS/M.Sc(Science) in Chemistry
Doctorate: Doctorate Not Required
Contact Details:
Company: MNEAL PHARMACEUTICALS PRIVATE LIMITEDAddress: Amneal Pharmaceuticals Pvt. Ltd. Plot No 15,16,17 Pharmez, Village: Matoda, Sarkhej Bavla Road, Ahmedabad - 382213
Location(s): Ahmedabad
Website: https://www.amneal.com/
Keyskills: LIMS Environmental Monitoring Stability Process Validation GLP reviewer Water Analysis Capa Change Control QMS RM Quality Assurance Deviation PM HPLC Quality Control
Amneal Pharmaceuticals
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is an integrated specialty pharmaceutical company powered by a robust U.S. generics business and a growing branded business. Together, our nearly 6,000 colleagues are working to build one of the most dynamic pharmaceutical companies in our rapidly changing i...
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