Eugia Pharma - Assistant General Manager - MSAT - Validations

Position : AGM - MSAT (Validations)

Experience : 14 to 17 years.

Designation : Assistant General Manager

Qualification : M. Pharmacy / B.Pharmacy

Experience from sterile formulation industry (Injectable)

No.of Vacancies : 1

Job Description :

1.Responsible for overall monitoring of MSAT activities with respect to validations of the site.

2.To ensure compliance to validation master plan & to ensure its effective validation on changes.

3.Oversee all qualification & validation activities viz; equipment's, utilities, facilities and process (media fills) in the facilities.

4.To constantly upgrade the systems and procedures as per current updates and cGMP requirements by introducing new systems or by upgrading the current procedure / systems.

5.Review of Change controls, Process Non-conformances, Exceptions, CAPA, Quality Risk Assessment.

6.To ensure implementation & effectiveness verification of various action items generated during Change managements, Process Non-conformances, Exceptions, CAPA and internal audit observations etc. related to validations.

7.To ensure that all changes related to qualifications & validations are evaluated through risk-based approach using appropriate tools.

8.Providing training to validation team as per requirement.

9.Responsible for effective man-power utilization for the respective department.

10.To assist the auditors (customer and regulatory) during plant round and to provide relevant information, if required.

11.To perform Gap analysis at regular interval to identify any gaps in quality system with respect to change in SOP.

12.To prepare & implement action plan as per guidance of Head of the department.

13.To review and ensure compliance to all observation during Internal audits.

14.Implementation and assure compliance to quality policies and procedures.

15.Ensure timely training of team members as per schedule.

16.Review of SOPs, Protocols and Reports etc. whenever required.

17.Ensure vendor performs qualification / validation activities in adherence to requirements of validation master plan.

18.Ensure vendor is trained in site relevant procedures / practices.

20.Be a part of Quality Risk Management as per requirements and conduct assigned activities.

21.Responsible for issuance of all the Validation related documents in DMS system.

22.Review of change controls and verification of CAPA and execution of the same

23.Review and Initial approval of PNC.

24. To meet the business requirements of all plant's(I.e E-1,2,4 & 5) validation documents and QMS activities shall be reviewed and approved.

(ref : iimjobs.com)