Opening in Amneal – Injectable Quality Control function
We are looking for competent, dynamic and motivated candidates for suitable positions for Injectable unit for our Ahmedabad SEZ Matoda & Palli plant.
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: 30
Area: GLP, Calibration, HPLC, QC-QMS, LIMS, Stability, RM, PM, FP, IP, Stability, Analysis, Testing, reviewer etc.
- Testing of raw material, packing material, in-process, finished product and stability samples (as per stability protocol).
- To keep neat and cleanliness at work place and follow the Good laboratory practices in the laboratory.
- To keep update of instrument slog-books and to record the data in LNB during testing. To attain and complete self-training record.
- To initiate and review of A)Deviation B)Out of specification/Out of trend C)Change control
- To ensure in and out of stability samples from stability chambers.
- Charging of stability samples as per stability protocol.
- To perform water analysis as per specification, SOP and GTP.
- To co-ordinate QA for documentation for issuance and retrievals.
- Review and monitoring of USP, EP, BP and other pharmacopeia monographs for changes/ revision.
- To prepare COA of various product/material as per requirement whenever required.
- LIMS master preparation for various product / material/ instruments/ Volumetric solutions etc.
- Registration of reference standard, working standard, column, instrument etc. in LIMS
- Preparation/updating of calibration schedule in LIMS
- Updating of LIMS master as and when required
- Preparation of configured Test plan.
- 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.
Interested candidate can share CV on email@example.com & relevant profile candidate’s telephonic interviews will be planned.