Sr. Executive - Validation

• Role & responsibilities :

• prepare and review Validation Master Plan (QMP, VMP, PVMP, CVMP and 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.

• 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.

• 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.

• To participate and monitor execution of Media fill / Process Validation Batches.

• Review of required calibration reports, preventive maintenance and breakdown reports.

• To review Computer System Validation documents.

• To Support the IPQA and QMS for In-Process activity and for building QMS system respectively.  

• 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 / Head time to time.

Preferred candidate profile : The candidate must have minimum 7 years of Experience in Equipment qualification & validation in Formulation OSD plant. Also his minimum qualification should be B. Pharm.