Novartis Job Vacancy For B.Pharm M.Pharm MSc
Post Name: Executive QA ONCO
Education: B. Pharm/M. Pharm/M.Sc. from reputed institute
Experienced: 5-10 years, preferably in oral solid Dosage (Experience in Oncology would be preferred)
Location: Navi Mumbai
Job Description: Hiring For Executive QA ONCO in Novartis!
Job Purpose:
Highly skilled & experienced Quality professional who contributes by supporting of QMS & Oversite of GMP activities at Oncology site.
Your key responsibilities:
Your responsibilities include, but are not limited to:
• 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. Follow Quality behaviors
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