Home Production Manager CMC- QA | Sun Pharma | Vadodara

Manager CMC- QA | Sun Pharma | Vadodara

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Sun Pharma is the Fastest Growing Pharmaceutical company in the world with 2000 Products, above 30,000 workforce Presence in Over 100 Countries and Manufacturing Facilities in 40 Countries.

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Sun Pharma recognizes its employee’s passion for growth and empowers them to achieve their aspirations. We owe our success to our passionate and skilled workforce. At Sun, one can work with an inspiring, approachable, and visionary leadership. Our open, enabling and trust-based culture will offer you an exciting environment to work and excel in your chosen career.

Designation: Manager CMC QA

Location: Vadodara, Gujarat, Maharashtra

Job Description:

  • To provide support to the group to ensure achievement of CMC Quality accountabilities and responsibilities of Baroda R&D.
  • To be accountable for developing procedures/systems and for assuring compliance to them by the R&D function.
  • To ensure the Compliant Development of Chemical Entities, Key starting Materials, Intermediates, API, and their technology transfers to the manufacturing organization.
  • Review and audit R&D procedures, specifications, stability data, reports, and SLP/Process packages, and other technology transfer documents of drug substance / Intermediates development for completeness & adequacy and justified prior to transfer to manufacturing sites

  • To assure that process development packages up to filling Stage of R & D deliverable is reviewed adequately within the team to verify scientific rigor, adequacy, and completeness.
  • To implement and monitor enabling processes/practices, such as the R&D stage-gate process, development standards, and acceptance criteria.
  • To ensure the Compliant Development of Analytical Method, Method Qualification, and Method Validation activities related to Chemical Entities, API, and their method transfers to the manufacturer organization.
  • Review of Harmonization Sops, Guidelines and implementation
  • Review of facility and equipment qualification and calibration records
  • Support and participate in failure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited
  • Reviewing deviation/Change controls / CAPA and associated investigation reports prior to Technology Transfer

Qualification: M.Sc, B.Pharma/M.Pharma

Experience: 8-13 Years

Salary: Negotiable

Contact Details:

vignesh.iyer@sunpharma.com

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NoteSun Pharma does not seek payment of any kind from prospective candidates for employment with Sun Pharma or authorize any agency or any individual to collect or charge any fees or charges for recruitment. Please be cautious while dealing with any recruitment agency or anyone asking you to pay money representing himself to be representing Sun Pharma.


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