Assistant Manager - Quality Assurance. (Data Reliability)

Role & responsibilities.

• Review paper and electronic data related to GMP activities at the site to check adherence and compliance level with respect to data reliability requirements.
• Perform walkthrough of facility to check adherence and compliance level with respect to data reliability.
• Communicate identified discrepancies to responsible personnel at the site and CQ Data Integrity Cell and ensure the compliance along with review of compliance report from site and its effective implementation.
• Provide training to employees on the different topics related to data reliability and data security aspects.
• Prepare and maintain data reliability related documents at site.
• Review audit trail of electronic data system and verification of compliance against 21 CFR Part 11 requirements for electronic data generating systems.
• Review of data integrity risk assessment and Process design at site and ensure its implementation of mitigation.
• Implement data reliability related CQ initiatives at site as per guidance of Data Integrity Cell.
• Provide support to Data Integrity Cell during inspection.
• Review of data reliability investigations at site.
• Any other activities assigned by Head of Data Integrity Cell to support other functions/activities.

Preferred candidate profile

Candidates should have sound knowledge cGMP documentation and must be familiar with cGMP requirements. (Microbiology Experience Preferred)