Site Micro Head - Goa

1) Overall responsible for Microbiology departments across the site.

2) Monitor and ensure effective implementation of policies, procedures and systems to comply with

cGMP and GLP.

3) Provide technical guidance to the Microbiology team and Cross functional teams.

4) Ensure risk assessment is conducted wherever required to evaluate risk and implement mitigation

action.

5) Responsible for internal and external audit compliance and ensure extrapolation of the same to

respective Microbiology Laboratories.

6) Involvement in nonconformance investigation and corrective actions implementations.

7) Ensure timely completion of all the investigation and CAPA and closure within the due period.

8) To operate the Track-Wise, LMS, ARIBA, Cipdox, EM Signer software based on the roles and rights

provided in the application.

9) Imparting training to the staff on aseptic techniques during testing, Microbiological best laboratory

practices, investigations etc.

10) Monitor appropriate implementation of QMS in Microbiology department.

11) Ensure Microbiological tests methods are validated and verified as applicable.

12) Be informed on the new or revised regulatory guidelines related to Microbiology function and ensure

compliance.

13) Ensure the smooth day-to day activities in Microbiology Academy. Work with senior management to

develop training strategies for identified trainees in the academy.

14) Ensure Effectiveness check of SOPs applicable to Microbiology.

15) Approvals of SOP’s, protocols etc. applicable to Microbiology.

16) Ensure selection and recruitment of staff as per the qualification and role requirement.

17) Monitoring qualification and calibration of instrument / equipment’s, qualification of computer

systems, and administrative activities in all Microbiology laboratories.

18) Ensure proper review of Quality Budget received from Finance department.

19) Monitor utilization of Budget allotted to Microbiology department.

20) Responsible for all approvals related to QC X Department as Unit Head.

21) Any other assignment allocated by the Head Site Quality / Operation Quality Head.

22) Ensure appropriate inventory of Media, Glassware and all accessories required for operations in

Microbiology Laboratory.

23) Responsible for review and monitoring of Goa site water quality and implementation of corrective

and preventive actions.