Senior Executive, Qual Assr-ARPL-AQAQ AR

Job Summary

Responsible for effective review and approval of LIR’s / Deviations / lab events and closure of all the investigations in timely and compliant manner.

Job Responsibilities

1. Review and approval of lab investigation reports (LIR), Deviations, Anomalous results, Out of specification (OOS) and Out of trend (OOT) investigations
2. Review and approval of lab events and Temporary change controls.
3. To review laboratory data with respect to investigtions.
4. Co-ordinating with cross functional team for the closure of investigations in timely manner.
5. Responsible for review and approval of training sessions with respect to investigations.
6. Review and approval of CAPA
7. Review of LIR trend reports.
8. Follow up with stake holders for online closure of
9. Support to regulatory and customer audits
10. Work in a safe manner collaborating as a team member to achieve all outcomes.
11. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
12. Perform all work in support of our corporate values of Collaboration, Courage, Perseverance and Passion: Demonstrates strong and visible support of our values.
13. All other relevant duties as assigned.

Job Requirements

• Education
  • Minimum Bachelor of Pharmacy / Science or any equivalent degree.
• Experience
  • Minimum 6 years of experience in GMP regulated pharmaceutical industry.
• Knowledge, Skills and Abilities
  • Possess sound knowledge in quality management system which comprises of change controls, deviations and LIR’s
  • Hands on experience in Trackwise application, LIMS, SAP, Empower.
  • Technical skills in reviewing QC data.
  • Maintains good interpersonal skills and communication skills.