Job Description

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.