QA Auditor Job at Syngene, MSc Life Sciences Apply
Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
Job Location: Bangalore
Core Purpose of the Compliance QA Auditor: To perform the role as Compliance QA auditor to verify compliance to ICH-GCP, 21 CRF Part 11, and applicable regulatory requirements with respect to computerized systems and IT aspects.
Other Responsibilities:
- To perform or assist any other relevant job with relevant training as and when required by the Department Head or Management.
Role Accountabilities of a Compliance QA Auditor:
- Perform system audits with respect to computerized systems and IT aspects.
- Collate data for quality metrics and report.
- Perform vendor audits based on quality risk assessment.
- Follow the environment, health, and safety (EHS) requirements.
- To prepare and issue audit reports to the respective operations team in consultation with the Manager/Department Head.
- Review qualification and validation documents of computerized systems & software.
Syngene Values:
- Excellence
- Integrity
- Professionalism
Specific requirements for this role:
- Experience: 3 – 6 years
- Demonstrated Capability: Auditing skills, Understanding of regulations & Attention to detail
- Education: M.Sc. in Life Sciences or M. Pharm.
- Sound technical Knowledge in Computer System Validation, GxP Computerized Systems, and GAMP5 requirements
Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
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