CMC Quality Assurance Specialist

3 weeks ago

Vadodara, Gujarat, India SUN PHARMA Full time

Job Title:

CMC Quality Assurance Specialist

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 for reviewing and monitoring the R&D quality systems in development areas of API research & development at SUN Pharma, Vadodara.

Area Of Responsibility

  1. Provide support to the group to ensure the achievement of CMC quality accountabilities and responsibilities of Gurgaon R&D.
  2. Be accountable for developing procedures/systems and assuring compliance to them by the R&D function.
  3. Ensure the compliant development of chemical entities, key starting materials, intermediates, API, and their technology transfers to the manufacturing organization.
  4. 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 and adequacy and justified prior to transfer to manufacturing sites.
  5. Assure that process development packages up to filling stage of R&D deliverables are reviewed adequately within the team to verify scientific rigor, adequacy, and completeness.
  6. Implement and monitor enabling processes/practices, such as R&D stage gate process, development standards, and acceptance criteria.
  7. 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.
  8. Review of harmonization SOPs, guidelines, and implementation.
  9. Review of facility and equipment qualification and calibration records.
  10. Support and participate in failure investigations and resolution of root causes for issues related to systems and products developed within Sun Pharmaceutical Industries Limited.
  11. Reviewing deviation/change controls/CAPA and associated investigation reports prior to technology transfer.
  12. Knowledge on evaluation of nitrosamine impurities in drug substances, raw materials, intermediates.

Education and Job Qualification

A minimum of a master's degree in science/pharmaceutical science or M.Sc (organic chemistry) or M.Pharm (chemistry) or a related discipline and experience in the 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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