Position: Officer / Sr. Officer – Quality Control

Grade: G12C / G12B

No. of Position: 1 No.

Job Location: Ahmednagar

Qualification: M.Sc. (Chemistry)

Experience: 5 to 9 yrs experience in API manufacturing plant

 

Job Profile

To investigate LAB Event, OOS/OOT results, Un-Planned deviation, Planned Deviation in all Section and timely submit for approval. To prepare and review the laboratory investigation report hypothesis study / evaluation study protocol and reports. To review of Analytical data like packing material, In-Process samples, Intermediate samples, Raw material and Finished Product samples, Stability samples etc. To review of instruments log books and other log books like IC Column, LCMS Column and WRS Log books etc. To ensure effective review of physical and electronic raw data and records generated in QC laboratory Review sample set and instrument methods, custom field related activity in Empower 3 software To review Audit trail of laboratory instrument which are connected with software like EMPOWER, LAB X, LAB Solution etc. To co-ordinate and conduct self inspection (internal audit) and its compliance To execute and review change control proposals in TRACK WISE. To monitor the compliance with the requirements of Good Manufacturing Practice and Good laboratory practice. To participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement. To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. To conduct training program and ensure its effectiveness To Co-ordinate and manage with other department of the plant to build continuous quality in product and systems with technical support to get customer satisfaction. To co-ordinate with contract laboratory and full fill the requirements as per responsibilities section in technical / quality agreement and extend support as per requirements.