Title: Compliance QA Auditor
Job Title: Compliance QA Auditor
Job Location: Bangalore
About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.
At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit
Mandatory expectation for all roles as per Syngene safety guidelines
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
- Compliance to Syngene’ s quality standards at all times
Core Purpose of the Role :
- 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 computerised systems and IT aspects.
- Comfortable working and communicating professionally with others to reach understanding and agreement as necessary.
Other Responsibilities:
- To perform or assist any other relevant job with relevant training as and when required by Department Head or Management.
Role Accountabilities
- 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 computerised systems and IT aspects.
- Collate data for quality metrics and report.
- Perform system audits with respect to computerised systems and IT aspects.
- Perform vendor audits based upon quality risk assessment.
- Risk based review of system to ensure the critical controls in computerized systems
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
- Attend training on environment, health, and safety (EHS) measures imparted company
- To prepare and issue audit reports to respective operations team in consultation with Manager/ Department Head and follow-up the implementation of CAPA to ensure timely closure of audit observations.
- To assist for system audit as co-auditor and or providing input to Compliance QA team, if required.
- To review qualification and validation documents of computerized systems & softwares.
- To escalate immediately to Manager/ Department Head in case of any serious non-compliance to protocol and ALCOA+ principles.
Syngene Values
All employees will consistently demonstrate alignment with our core 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 Computeriused 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.