ive - CMC QA (API)

2 days ago

Vadodara, Gujarat, India SUN PHARMA Full time

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

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