Executive

Job Purpose :

Responsible for DS (MCM and CCM) IPQA activities. Primary Responsibility (Strategic, Operational, People, Financial responsibilities)

Strategic :

1. Maintain data integrity in all activities at site and ensure appropriate and adequate traceability.

2. Preparation, review and implementation of Standard operating procedures, Protocols etc., pertaining to Quality Assurance department, in line with Global GMP compliance regulations and industry practices related to Biopharma industry.

3. To ensure all time readiness for customer and regulatory audits and inspections.

4. To ensure the Quality Compliance of DS manufacturing, DS Warehouse and Engineering area activities.

Operational :

1. Involving in all in process Quality Assurance activities which are executed at shop floor. 2. Monitoring of raw material and product Dispensing, Manufacturing activities in DS Manufacturing.

2. Collection and submission of Cleaning validation, and Process validation and hold time batch samples along with TRF.

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JOB DESCRIPTION PAGE

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1. To ensure the cGMP compliance in the DS Manufacturing, Warehouse and Engineering areas.

2. Review of Master BMRs / BPRs and executed BMRs / BPRs of DS Manufacturing activities.

3. Review and Execution of all Qualification / Validation activities of Equipment / utilities / facility of DS manufacturing areas, Warehouse, and Engineering. Provide support for review and execution of qualification activities at shop-floor.

4. To support cross functional teams in handling Investigations for root cause analysis in related to any reported Deviations, OOS, OOL and OOT.

5. Review of Change controls and support in closure of action items by ensuring compliance to inhouse and regulatory guidance.

6. Responsible for handling of cell banks.

7. Preparation and Review of Quality Risk Assessment Protocols and Reports.

8. Providing line clearance for manufacturing and warehouse (DS).

9. Handling of other responsibilities (As applicable) assigned by Reporting Manager and Head of the Department.

Finance :

1. Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (I

2. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product. process or site.

People :

1. Champion the Stelis Core Values and lead by example by acting a member of a team to achieve organizational and common objectives.

2. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan