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08/09 Ratan Kumar
HR at Alloys Consulting

Views:1756 Applications:196 Rec. Actions:Recruiter Actions:135

Manager - QA Validation & QMS - Pharma (10-15 yrs)

Ahmedabad/Gujarat Job Code: 24697

Responsibilities :

- The candidate should have experience in both QA Validation and QMS.

- Candidates should have experience in the Pharmaceutical industry as well.

Required Qualification :

- Graduation of Post Graduation in Pharma

Validation :

- Planning and execution of validation and qualification activity

- To review the Validation Master Plan.

- Prepare the Re-validation schedule and execute the activity as per schedule

- To update validation master plan.

- To review the Media Fill Protocol and report

- Execution for Process validation.

- To review Hold Time Study protocols and reports.

- Handling Cleaning Validation.

- Planning and Execution for HVAC system with Third party.

- Review the URS, DQ, IQ, OQ, and PQ Protocol and report.

- Coordination with engineering and involvement in qualification and validation activities when it is going on.

- To monitor validation qualification activities and review.

QMS :

- To approve or reject the vendors supplying raw materials, packaging materials

- To select and approve the vendors supplying items directly going in aseptic processing.

- To ensure in day to day that raw materials, packing materials, products under quarantine,

- Finished product ready for sale are stored as per required storage conditions.,

- To approve / authorize all master documents like SOP- s, Formats and Exhibits, Master Formula cards, Master Batch Manufacturing and packing records, customer related quality documents etc. and ensure that all are updated to date.

- To approve all qualification and validation documents of critical systems and equipment.

- To ensure the timely execution of self inspection, vendor audits, revisions of documents .

- To ensure that customer products and materials are handled as per their requirements and provide any document if required for that.

- To lead the team for Quality Complaints investigation, review of investigation process for root cause, instruct to carry out any further actions to be taken and finally approve the complaints investigation report.

- Decide on CAPA and follow through for Implementation.

- To ensure day to day QA controls are at place and make QA empowered for the entire plants

- QMS and GMP. If required, will intervene and call meeting to resolve any confusion.

- To ensure timely completion of all documentation in consultation with all department heads.

- To ensure timely calibration, preventive maintenance and qualification/ validations including media fill ( aseptic process validation).

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