Compliance Monitoring – Manufacturing | Arcolab | Bangalore

Job Description

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

Technical competencies:

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.

Behavioral Skills:

1. Communication & Influencing

2. Discipline and self-motivated

3. Focused and committed.

4. Ownership attitude.

Primary Responsibility:

  • 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.

Location