Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Executive QA ONCO
Highly skilled & experienced Quality professional who contributes by supporting of QMS & Oversite of GMP activities at Oncology site.
Your key responsibilities:
• Review of Equipment/ System Qualification documents (URS, DQ, IQ, OPQ etc.). Review of key validation documents for Computerized Systems and ensure that the expectation of 21 CFR Part 11 are satisfied implemented through adequate review.
• Review for distribution and monitoring of annual schedule for periodic review for need of re-qualification of Equipment/ System to all departments. To archive and maintain qualification documents.
• Preparation, review and/or approval of Quality Risk Assessment. Periodic overview of GMP activities. Review of calibration and preventive maintenance activities of manufacturing/QC equipment. Review/ Approve of SOP and documents related to equipment/system qualification.
• Periodically supervise the corrective and preventive action and to expedite for closure and extension of corrective and preventive actions within the stipulated timeline. QA oversight on QC, Production, warehouse, engineering department, Utility, Service Floor, calibration and maintenance activities etc.
• To review/ approve periodic review reports for need of re-qualification of equipment/system. Issuance of GMP documents. Release/Rejection of SFG in SAP.
• Perform periodic user management of standalone and network systems as an Administrator for Laboratory & Production instruments/Equipment’s. Review of executed batch manufacturing record (BMR), Batch packing records (BPR) and Electronic batch record (EBR). Ensure compliance with Novartis / Sandoz regulation and SOP / Pharmacopoeia/Group requirements / local and International authorities.
• Maintain confidentiality and ensure safe custody and efficient handling of company document / material. Perform any other task that may be assigned for running of the company as per latest quality standard and Novartis Corporate Guidelines.
• Ensure efficient inter and intra department communications. Any other responsibility that may be assigned by supervisor/Manager from time to time.
• B.Pharm / M.Pharm / M.Sc. from reputed institute
• 5-10 years, preferably in oral solid Dosage (Experience in Oncology would be preferred).
• Collaborating across boundaries Functional Breadth with min 3-5 years’ experience in Quality assurance of Pharma/Manufacturing sector such as analytical lab, Manufacturing, engineering in a GMP environment/equivalent.
• Qualification activities, Vendor management Investigation, QMS, Audit, Quality Control & Other GMP activities.
• Quality decision making, Knowledge of IT Applications & tools, Knowledge of TQM and related industry. GxP standards and processes
Experience : 5-10 years
Qualification : B.Pharm / M. Pharm / M.Sc
Location : Navi Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality
End Date : 25th August, 2021
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