Site Quality Head

Job Responsibility :

1. To ensure preparation, review and approval of all procedures, in line with the regulatory guidelines / expectations, identify the gaps and update the procedure. The master documents of the site like VMP, SMF, APQR, QSP, etc. are to be ensured for such compliances from time to time.

2. To handle the day today changes, deviations, incidents, market complaints, OOS, OOT are investigated in line with regulatory expectations in time bound fashion.

3. To develop second line personnel's by training the operating level and supervisors / reporting authorities to evaluate and implement the risk and science-based approach in decision making.

4. To coordinate with different functions like R&D, production, engineering, RA, purchase,

compliance, marketing etc. to bring about a robust system to ensure that it meets the regulatory

5. Ensure that the analytical tech- transfer is a well- planned process and successful at the site

6. To conduct training for all technical staff, inculcate the culture of quality and compliance, and have the schedules adhered to as per the training calendar.

7. To host the audits by customers and regulatory authorities. To take active participation in technical discussions with the customer and suppliers and implement actions at the site to improve total customer satisfaction.

8. To provide regulatory / customer audit response in conjunction with corporate quality and deep track on the CAPA's for time bound closures.

9. To be actively involved in all investigations related to the quality issues at the site, to help the marketing team and the customers get the required technical clarifications in a timely manner, etc.

10. To identify, understand and evaluate the need for infrastructural requirements and to organize for the timely procurement of such requirements to improve the efficiency and effectiveness of the quality functions.

11. To derive mechanism for measurement of productivity and achieve organizational goal of QA&QC.

12. To ensure all marketing requests are responded to in a timely manner.

13. To track and update closure of all quality notifications in a timely manner.

14. To ensure quality trends of products are prepared and reviewed in timely.

15. To ensure all regulatory queries related to analytical validation are responded to in a timely

manner.

16. To ensure all qualification and Validations are successfully carried out as per schedule.

17. To ensure Annual Product Review is prepared and approved in a timely manner.

18. To steer and participate Quality Management review of Level-1 and level-2 at site.

19. To participate in Quality Management review level-3 and present it to the top Management.

Preferable candidate should be from Biotech / Pharmaceutical API industry only & also having experience in Microbial Fermentation (Classical)