Experience

inglasia pharma solutions

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• GMP/GDP Quality Assurance Manager

  • Feb 2022 - Present

  • Acting as Responsible Person named on MHRA WDA• CEIV GDP trained• Implementation & Improvements for QMS – GDP/GMP• Performing Gap Assessments• GMP/GDP Audits• Delivering GDP training• Supporting CSV and Validation projects• Completion of Risk Assessments for both Transportation and critical processes • Acting as Responsible Person named on MHRA WDA• CEIV GDP trained• Implementation & Improvements for QMS – GDP/GMP• Performing Gap Assessments• GMP/GDP Audits• Delivering GDP training• Supporting CSV and Validation projects• Completion of Risk Assessments for both Transportation and critical processes



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Supplier Quality Officer

  • Feb 2018 - Present

  Responsible for Supplier and customer audits (completed more than 100 Audits onsite and Desk-top), Periodic reviews, Quality Agreements, Supplier assessments. Preparation of Dynamic Risk Matrix, Quarterly supplier reviews. Performed Risk Assessment and mitigation using different tools. Performed Self Inspections and Annual product quality review annually.Achievements: • Independent Lead Auditor – Pharmaceuticals and Medical Devices audits (which include ISO 13485 and ISO 9001 suppliers) completed successfully.• Handled Quality Councils, Visual Boards during team meetings and successfully completed Supplier quality matrices to enable supplier performance visible to the wider team.• Supplier Approval process completed through assigning of criticality till the audit of the suppliers• Supplier Periodic reviews completed on time.• Completed 20 Quality Event closure including 5 Why and Fishbone diagram preparation in the year 2020• Supplier Quality Support including preparation and approval of Quality Agreements• Risk Assessment of the suppliers successfully completed with details of risk mitigations.• Preparation and revision of level 1 documents e.g. Site Master File, Validation Master Plan.• Preparation and review of SOPs and ensure that all work in manufacturing and supporting departments is in full compliance with cGMP, 21 CFR and EU-GMP.



BTG plc

• United States
• Medical Device
• 200 - 300 Employee

• Quality Lead

  • Feb 2013 - Feb 2018

  Responsible for Equipments and Process Validation. Management of Contractors on Site. Adherence of Validation Master Plan to carry out Equipment and process Validations. Validation Documentation Tracking and Validation Template Preparation. Protocol /Document preparation: URS, VAR, IQ, OQ, PQ, PPQ, TM and VSR. Carryout execution of IQ, OQ, PQ and PPQ. Apart from the Validation activities, associated NCR closing, Quality Event closure through Trackwise and Timely closure of Change Control actions. Participation in MHRA and FDA Inspection for Verithena product. Adherence of 21CFR and EU-GMP into day-to-day operations. Medical device validation and Verification activities. Product/Process Performance Qualification and Quality Event closure including 5 Why and Fishbone diagram preparation. Oracle and SAP knowledge is added advantage. Supplier Quality Support including preparation of Quality Agreement and conducting supplier audit. Quality Assurance support for Batch release, Complaint Handling, Review of Quality Events, Change control closure, APQR preparation and approval.



Assencion Pharmaceutical Ltd

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Contract Responsible Person

  • Jul 2012 - Feb 2013

  Assencion Pharmaceuticals Ltd, Contract Responsible Person. RP number: 8814796. Assencion Pharmaceuticals Ltd, Contract Responsible Person. RP number: 8814796.



Auden Meckenzie (Pharma Division) Ltd.

• Asstant Manager QA

  • Dec 2010 - Jun 2012

  Responsible for Maintenance of Quality Management System, Leading Internal Audit and External audit programs, Preparation of Technical Agreements and Confidentiality Agreements, Provide Technical and Quality guidance to all the other departments, ensuring compliance with all current regulations for all work performed, Managing the documentation systems (SOP’s, Deviations, OOS, Change Management etc.) Support the Qualified Person in release of batches, Verification of Validation and Qualification documents including water systems. Provide GMP and GDP training for technical staff.



Claris Limited

• India
• Investment Management
• 300 - 400 Employee

• Asst. Manager QA

  • 2002 - 2010

  Responsible for Quality Management System including handling of Deviations, Change Controls and CAPA’s. Handled the functions of In Process Quality Assurance and Batch Release, Internal and External Audits conducted for RM, PM and PPM.Q.A. Documentations, Validation, Qualification of equipments in formulation plant & Handled Qualification & Validation activity during project stage at Cephalosporin Plant of Claris Lifesciences limited, Ahmedabad,Gujarat (India). Responsible for Quality Management System including handling of Deviations, Change Controls and CAPA’s. Handled the functions of In Process Quality Assurance and Batch Release, Internal and External Audits conducted for RM, PM and PPM.Q.A. Documentations, Validation, Qualification of equipments in formulation plant & Handled Qualification & Validation activity during project stage at Cephalosporin Plant of Claris Lifesciences limited, Ahmedabad,Gujarat (India).