Arcolab Pvt Ltd Job Vacancy for B Pharm/ M Pharm/ B Tech Biotechonology
Dev.kiran@arcolab.com
Location: Doddaballapura - Bangalore
Purpose: To implement & execute the Continued Manufacturing Compliance (CMC) at Stelis.
Education: B.Pharm or M.Pharm or B.Tech-Biotechonology
Experience: Relevant experience of 7 to 15 Years in Pharma or Biopharma manufacturing Technical competencies:
JD
1. Hands on experience of Biopharma production process and equipment of DS manufacturing or Manufacturing QA
2. 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 standard process 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 the compliance. Follow up & tracking of QMS events initiated through CMC
observations to ensure timely & effective closure.
Periodic review of the check points and revise/modify the check sheets time to time as and when required. Identify and implement continued improvement initiatives to meet the 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.
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