Sun Pharma is the fourth largest generic pharmaceutical company in the world It is also India's largest and most valuable pharmaceutical enterprise by size and market capitalization. The company provides high quality medicines trusted by customers and patients in over ISO countries and has multiple manufacturing facilities and R&D centers. Our leadership is approachable, recognizes people's passions for growth, gives them a voice and empowers them to make a positive change.
Post : Senior Executive - Research Quality Assurance
Job Description
• Conduct audit of Clinical phase of BA / BE studies, which includes in-process audits, retrospective audits etc.
• Conduct sponsor QA oversight audits of Clinical phase for outsourced BA/BE Studies (conducted in patients and/or in healthy volunteers).
• Review study documents (e.g. study protocol, study plans, IB, ICFs, clinical study raw data/ report etc.) of BA/BE studies in order to ensure compliance with applicable guidelines, regulations and Good Documentation Practice (GDP).
• Conduct Contract Research Organization (CRO)/ Contract Service Provider (CSP) / Material supplier Qualification/ Re-qualification audits.
• Perform other QA audits like System / Facility / Process based audits.
• Create (review and / or coordinate) & implement Quality Assurance (QA) Standard Operating Procedures (SOPs) and global documents (GQSs/ GSOPs). Review and support creation of operational level SOPs in collaboration with relevant stakeholders at R&D.
• Review Deviation, Incident, Investigation, CAPA and change control, instrument qualification (IQ/OQ/PQ/DQ) etc.
• Review and approve documents related to Computer System Validation.
• Prepare audit reports within timely manner; identify any non-compliance/ non-conformance and escalate any critical issue immediately with the senior management (Head, GCP QA/ Head- Site GCP QA and Quality R&D Head), as applicable.
• Support creation of appropriate Corrective Action and Prevention Action (CAPA) plan and its execution to meet necessary compliance standards. Verify adequacy of all created & executed CAPAs.
• Responsible for document control and document management.
• Impart or assist in imparting training on applicable guidelines, regulations, SOPs etc.
• Execute any other work allotted by the reporting authority.
Location : Tandalja - R&D
Last Date : 10th July, 2023
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