Experience

Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global QA Auditor

  • Nov 2022 - Present

  Mumbai, Maharashtra, India Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers. Provide consultation to… Show more Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers. Provide consultation to Novartis business units through risk-based assessments. Act as SME for assigned areas of responsibility. Support the strategic development of an effective global risk-based audit strategy and program. Lead, conduct, plan, document, and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents. Managing more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success. Provide technical guidance, mentoring, and training on audit activities. Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing. Escalation of critical findings and support immediate follow-up measures according to Novartis requirements on Management Escalations. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee. Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.

• Manager - External Supply

  • Jul 2018 - Oct 2022

  Mumbai, Maharashtra, India Responsible for managing quality aspects at external suppliers for External Supply QA / Chemical Operations and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual. Direct reporting line to the Head of Chemical Operations / ESO QA.



Cipla

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Deputy Manager

  • Dec 2016 - Jul 2018

  Mumbai, Maharashtra, India Vendor qualification



Torrent Pharmaceuticals Ltd

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Assistant Manager, CQA

  • Apr 2015 - Dec 2016

  Ahmedabad, Gujarat, India Vendor qualification of Indian CMOs of European subsidary (Heumann & Aptil) Formulation facility audit for evaluation of GMP compliance. Sorting of vendor based on document review. Review site master file. Preparation of audit plan and audit agenda for site audit. Packaging material manufacturing audit. Preparation and review audit report. Tracking of compliance for pending audit observations. Preparation & Periodic review of Quality agreements. Discussion with… Show more Vendor qualification of Indian CMOs of European subsidary (Heumann & Aptil) Formulation facility audit for evaluation of GMP compliance. Sorting of vendor based on document review. Review site master file. Preparation of audit plan and audit agenda for site audit. Packaging material manufacturing audit. Preparation and review audit report. Tracking of compliance for pending audit observations. Preparation & Periodic review of Quality agreements. Discussion with Procurement and Projects for vendor qualification. Review documents according to product requirement. Preparation of query reports for products & Discuss with vendor for the compliance of queries. Provide inputs for market complaints. Maintain and updation of database for products. Preparation of SOP for Quality assurance department. Training of SOPs. Preparation of Quarterly & Annually Quality review presentations.

• Executive - CQA

  • Dec 2009 - Mar 2015

  Ahmedabad Area, India Vendor qualification of Indian CMOs of European subsidary (Heumann & Aptil) Sorting of vendor based on document review. Review site master file. Preparation of audit plan and audit agenda for site audit. Formulation facility audit for evaluation of GMP compliance. Packaging material manufacturing audit. Preparation and review audit report. Tracking of compliance for pending audit observations. Preparation & Periodic review of Quality agreements. Discussion with… Show more Vendor qualification of Indian CMOs of European subsidary (Heumann & Aptil) Sorting of vendor based on document review. Review site master file. Preparation of audit plan and audit agenda for site audit. Formulation facility audit for evaluation of GMP compliance. Packaging material manufacturing audit. Preparation and review audit report. Tracking of compliance for pending audit observations. Preparation & Periodic review of Quality agreements. Discussion with Procurement and Projects for vendor qualification. Review documents according to product requirement. Preparation of query reports for products & Discuss with vendor for the compliance of queries. Provide inputs for market complaints. Maintain and updation of database for products. Preparation of SOP for Quality assurance department. Training of SOPs. Preparation of Quarterly & Annually Quality review presentations.



Glenmark Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Trainee

  • Aug 2008 - May 2009