SUN PHARMA Senior Executive

2 weeks ago


Vadodara, Gujarat, India SUN PHARMA Full time

Job Title: SUN PHARMA Senior Executive - CMC Quality Assurance

Job Summary: We are seeking a highly skilled Senior Executive - CMC Quality Assurance to join our R&D Quality, CMC QA team at SUN PHARMA.

Key Responsibilities:

  • Support the group to ensure achievement of CMC Quality accountabilities and responsibilities.
  • Develop and implement procedures/systems and ensure compliance to them by the R&D function.
  • Ensure 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 for completeness and adequacy.
  • Implement and monitor enabling processes/practices, such as R&D stage gate process, development standards, and acceptance criteria.
  • Ensure compliant development of Analytical Method, Method Qualification, and Method Validation activities related to Chemical Entities, API, and their method transfers.
  • Review Harmonization Sops, Guidelines, and implementation.
  • Review 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 PHARMA.
  • Review deviation/Change controls/CAPA and associated investigation reports prior to Technology Transfer.
  • Knowledge on evaluation of Nitrosamine impurities in drug substances, raw materials, intermediates.

Education and Job Qualification: A minimum of a Master's Degree in the Science/Pharmaceutical science/or M.Sc (Organic Chemistry) or M.Pharm (Chemistry) a related discipline and experience in pharmaceutical industry is required.

Technical Competencies: Literature search methodologies, Sound knowledge of process chemistry, Ability to analyze chemistry problems, Ability to proactively understand scale issues and resolve them, Knowledge of material (raw materials, solvents etc.) and product (intermediate, API), Understanding of major IP, Regulatory guidelines globally, Knowledge of GxP (GLP, GMP etc.), Knowledge of EHS in order to develop safe processes, Knowledge of QbD.

Experience: Minimum of ten years of experience within the pharmaceutical industry in Development Quality Assurance/ Quality Assurance (API manufacturing).



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