BDR Pharmaceutical Ltd.(Halol)
Vacancy Details :-
Department Name :- Qualification & Validation
Position :- Executive
Qualifications :- B.Pharm/M.Pharm
Experience :- 3-7 Years Experience
Job Description:-
- To 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 (SOP’s) 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.
Important Details :-
Job Location :- Baska,Halol
How to Apply :-
Intrested Candidates Apply Now
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