Job Description

Job Title:



Sr Executive - CMC QA



Job Grade:



G11





Department:



R&D Quality, CMC QA



Location

Baroda





Manager's Job Title:



Sr. Manager -1



Department Head Title:



Quality R&D Head







Job Summary





This position R&D Quality, CMC QA team member is responsible to Review and Monitor the R&D quality systems in Development areas of API Research & Development at SUN Pharma, Vadodara







Area Of Responsibility





• To provide the Support to group to ensure achievement of CMC Quality accountabilities and responsibilities of Gurgaon R&D.
• To be accountable for developing procedures / system 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 are reviewed adequately within the team to verify scientific rigor, adequacy, and completeness.
• To implement and monitor enabling processes / practices, such as 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
• 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.


Overall pharmaceutical industry experience in Quality Assurance and/or in a research environment is desirable.


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 (10) years of experience within the pharmaceutical industry in Development Quality Assurance/ Quality Assurance (API manufacturing)