Title:  Sr.Executive - CMC QA (API)

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

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)