Sr. Officer - QA (Equipment Qualification & Validation - Injectable)

Role & responsibilities :

To prepare and review Validation Master Plan (VMP), Qualification Master Plan (QMP) and Computer System Validation Master Plan (CSVMP). 

To follow the validation master plan.

To prepare and review Qualification and Validation Documents and execution as per protocol.

To update equipment and utility periodic requalification / re-verification schedules on monthly basis or whenever required.

Handling and storage of all quality document like BMR, BPR, log book, Protocol and SOP throughout life cycle.

To prepare and review standard operating procedures (SOPs) and procedures relating to qualification and validation.

Preparation and review of URS, FS, DS, DQ, RA, IQ, OQ & PQ and summary reports for Equipment, System and Utilities.

Coordination with cross functional team to perform qualification / requalification and validation activity.

Addressing any deviation identified during qualification / requalification and validation activity.

Performing qualification and requalification activities using data loggers / validator.

Issuance, retrieval of logbooks and ensure integrity of book of records. Training department activities handling.

To participate in investigation.

To support in change management, deviations, CAPA and all other quality management systems as and when required.

Review of required calibration reports, preventive maintenance, and work request and breakdown reports.

Work in teams. Work along with cross functional team, Work by adhering to discipline of the site and organization, protect the property of the organization.

Any other work assigned by reporting authority / Lead / Head time to time.

To support the IPQA and QMS for in-process activity and for building QMS system respectively.  

Preferred candidate profile : Candidate Must be having experience in Injectable Equipment and Utility qualification like Autoclave, vial washing machine, vial depyrogenation tunnel, Manufacturing vessel, Lyophilizer.