Officer - QA (Process & Cleaning validation - Injectable)

Role & responsibilities :

To prepare and review Validation Master Plan (VMP, PVMP, CVMP, QMP). 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, Report and SOP throughout life cycle.

To prepare and review standard operating procedures (SOP's) and procedures related to qualification and validation.

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

Preparation and review of PPQ and cleaning validation protocol and summary reports.

Monitoring of PPQ and cleaning validation activities.

Coordination with cross functional team to perform qualification / requalification and 

validation activity.

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

To participate in investigation.

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

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

To perform all the tasks assigned by the senior or reporting authority.

Preferred candidate profile : Person must have minimum 1-2 years of experience in Process Validation & Cleaning Validation in Injectable plant.

Perks and benefits