Manager/ Sr. Manager / Quality Assurance (FEV)

Role & responsibilities

Job Responsibilities/Descriptions

1.0 Knowledge on Guidelines (ISPE, PDA, ICH) regulation (FDA & EMA).

2.0 Participate in Equipment, Area, Utilities and Facility qualifications.

3.0 Preparation and Review of URS, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Commissioning Studies, and SOPs related to Equipment/systems.

4.0 To monitor the Performance Qualification of various equipment and systems at site.

5.0 Review of Performance Verification protocols and reports.

6.0 To be part of process validations studies like Washing Validations, Mixing Validations, CIP and SIP validations, Filling Validations, Capping Validations, Autoclave, DHS Validations and providing support for preparation and review of summary report.

7.0 Review and verification of Calibration, Preventive Maintenance and Annual Maintenance records of equipments related to GMP Area.

8.0 Handling of Qualification related change controls, Deviation and CAPA initiation and closure.

9.0 Handling and knowledge on breakdowns, Notifications, and clearance request.

10.0 Basic knowledge on 21 CFT part 11 requirements.

11.0 Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. Identify and mitigate risks related to computerized systems at the site level.

12.0 Preparation and review of the SOPs related Qualification, validation (Including CSV) and review of Engineering SOP.

13.0 To ensure the Audit trails and data integrity compliance for GxP computerized systems.

14.0 Reviewing and approving (or rejecting) validation or qualification protocols and or reports.

15.0 Providing Quality oversight on engineering activities.

Knowledge on Preventive maintenance and Calibration.

Preferred candidate profile