Compliance Monitoring – Manufacturing Pharma/ Drug substance
Purpose: To implement & execute the Continued Manufacturing Compliance (CMC) at Stelis.
Education: B.Pharma or M.Pharma or B.Tech Biotechnology
Experience: Relevant experience of 7 to 15 Years in Pharma or Biopharma manufacturing
1. Hands-on experience in Biopharma production process and equipment of DS manufacturing or Manufacturing QA
2. A Sound understanding of GMP systems and Processes.
3. Good Knowledge of Microsoft Excel, PPT, and other office tools.
1. Communication & Influencing
2. Discipline and self-motivated
3. Focused and committed.
4. Ownership attitude.
- Monitor compliance in DS manufacturing (Microbial & Mammalian) through the standard processes and assessment sheets and work for compliance improvement.
- Implementation & execution of Continued Manufacturing Compliance (CMC) heat map assessment sheets for different sites of Stelis.
- Design the effective check sheet(s) for respective sections and functions in order to improve and monitor compliance.
- Follow-up & tracking of QMS events initiated through CMC observations to ensure timely & effective closure.
- Periodic review of the checkpoints and revise/modify the check sheets from time to time as and when required.
- Identify and implement continuous improvement initiatives to meet organizational/business objectives.
- Support the cross-function team to up-keeping of facility/systems/procedures/documentation etc.
- Review of GxP practices at the site.
- Ensure all identified instruments /equipment and associated software are meeting the 21 CFR-Part 11 compliance.
- Review and harmonize procedures.
- Preparation of monthly reports for CMC activities.