Head - Site Quality Operations, Corporate Quality & Development Quality Assurance - Jenburkt Pharmaceutical Ltd.
(2022-03)
TGA, SAHPRA, EU-GMP, WHO-GMP Approved. Lead the Quality Management Team and manage the entire Quality Management System for GOSD, Liquid Oral, Ointment/Cream Formulations, Third-Party Injectables and Wellness Products, reporting directly to the Managing Director.
- Own compliance and effectiveness of audit observations (internal/external) and regulatory observations across the organization.
- Chair monthly Quality management meetings across site management to improve functional performance; present minutes to the Managing Director.
- Oversee Quality Assurance activities for CMO/CDMO and service-provider operations, ensuring GMP and GDP compliance through periodic audits.
- Direct process validation, equipment validation, hold-time studies (clean and dirty equipment), and cleaning validation.
- Approve and control qualification of process equipment, HVAC, water systems, and analytical instruments (standalone and networked) through URS, vendor evaluation, FDS, DQ, FAT, SAT, IQ, OQ, and PQ.
- Support quality risk assessments and QMS review, evaluation, and approval of Change Control, Deviation, OOS, OOT, market complaints, and CAPA, ensuring proper investigation, cross-department coordination, and trending to prevent recurrence.
- Deploy quality capabilities and standards across the APAC region; serve as lead auditor ensuring operational compliance with GMP legal and regulatory requirements.
- Hold overall accountability for site compliance and the QMS system, including quality oversight of 19 third-party CMO/CDMO manufacturing facilities under loan license and contract manufacturing.
- Lead the Corporate Quality Assurance (CQA) and Development Quality Assurance (DQA) teams alongside site Quality Operations and compliance.
- Direct overseas and domestic auditing programs for CMOs/CDMOs, track audit findings and trends, and lead qualification of manufacturing and testing facilities through audits and due diligence.
- Direct all Quality Operations activities for independent control and release of Jenburkt and CMO/CDMO pharmaceutical products.
- Collaborate with CMO/CDMO service providers on complaint and recall management, and lead people-management activities including recruitment, retention, training, and performance management for the Quality function.
- Led implementation of LIMS (Caliber 3.8.0.E) and assist in managing budgets for the Quality Organization.
Head - Quality Control and Compliance, Development Quality Assurance - Zenzi Pharma GmbH
(2018-02 - 2022-03)
WHO-GMP, EU-GMP, USFDA Approved. Led the Quality Assurance and Quality Control team for GOSD and Sterile Formulations, managing the full Quality Management System and reporting to the Global Quality Head.
- Held responsibility for GOSD and Sterile quality operations, including compliance and effectiveness checks of internal/external audit observations, warning letters, and regulatory observations.
- Directed process validation, equipment validation, hold-time studies, and cleaning validation.
- Chaired monthly Quality management meetings, presenting minutes to the Global Quality Head.
- Conducted GMP and Quality System audits across units, vendors, loan licensees, and CMO/CDMO/third-party sites; managed 7 loan-licensee Quality Operations, including product release, compliance, and quality.
- Served as lead auditor ensuring operational compliance with GMP legal and regulatory requirements; led new vendor qualification and mock pre-approval inspection programs for new product launches.
- Monitored CMO and external regulatory observations and emerging industry compliance trends to keep all sites inspection-ready with no major observations.
- Managed qualification and calibration of analytical instruments (HPLC, GC, Dissolution Tester, DT, KF, UV, Polarimeter, FTIR) including preventive maintenance and breakdown support.
- Ran external quality auditing programs for in-line and prospective CMOs, API suppliers, and critical starting-material suppliers across Zenzi Pharma subsidiaries; prepared APQR, BMR, and BPR documentation.
- Prepared CAPA programs following regulatory, customer, and external inspections; held quality accountability for 7 third-party/loan-license manufacturing facilities.
- Liaised with local FDA on product permissions and compliance; implemented new control-activity procedures plant-wide.
- Approved and controlled qualification of process equipment, HVAC, water systems, and analytical instruments (URS, vendor evaluation, FDS, DQ, FAT, SAT, IQ, OQ, PQ).
- Contributed to Computer System SOP upgrades, software audits, and GAP assessments; led and managed the Quality Operations team to ensure cGMP and QMS compliance at CMOs.
- Reviewed, evaluated, and approved Change Control, Deviation, OOS, OOT, market complaints, and CAPA with proper investigation and trending to prevent recurrence; supported senior management on Quality Operations budgeting.
Head - Quality Control - Kopran Ltd. (Qualigens Pharma Pvt. Ltd.)
(2016-03 - 2018-02)
MHRA, MCC, TGA, WHO-GMP Approved. Led the Quality Control team and managed the entire Quality Control Management System for GOSD Formulations.
- Performed vendor audits for raw materials and packaging materials; led method transfer and method development.
- Provided IT-related support to the organization and managed analysis of starting materials, finished dosages, and stability samples, including validation and qualification of instruments (AMV) and method transfer for OSD and liquid dosages.
- Conducted GMP and Quality System audits across units, vendors, loan licensees, and third parties; managed 3 loan-licensee sites for Quality Operations, compliance, and product quality.
- Supported new vendor development through sample evaluation, results assessment, and specification finalization in coordination with QA and Regulatory.
- Served as lead/supporting auditor ensuring operational compliance with GMP legal and regulatory requirements; communicated audit results to management and auditees via written reports.
- Ran external quality auditing programs for in-line and prospective CMOs, API suppliers, and critical starting-material suppliers across Kopran subsidiaries.
- Led and managed the Quality Operations team ensuring cGMP and QMS compliance at CMOs; led teams through successful regulatory inspections by MHRA, WHO, TGA, MCC, and EU-GMP.
Manager - Quality Control - Group Company of Strides Arcolab
(2014-11 - 2015-08)
USFDA, MHRA, MCC, WHO-GMP Approved. Held overall responsibility for Quality Control and compliance activities for GOSD and Sterile Formulations.
- Built and maintained a trained analyst pool capable of executing OOS investigations.
- Supported software compliance and data integrity initiatives; prepared STPs and tracked risks associated with SAP, LIMS, and Change Control.
- Managed analysis of starting materials, finished dosages, and stability samples, including validation and qualification of instruments (AMV) and method transfer for OSD and injectable products.
- Ensured and maintained valid Quality agreements with CMOs/suppliers, defining cGMP roles and responsibilities.
- Served as certified Track-wise investigator for OOS results and analytical deviations/events, performing root-cause analysis using multiple investigation tools.
- Supported new vendor development through sample evaluation and specification finalization with QA and Regulatory; served as Change Request Coordinator in Track-wise, managing evaluation, implementation, and closure of change requests.
- Built and led teams for regulatory inspections by MHRA, WHO, TGA, MCC, and EU-GMP, achieving successful completion.
Group Leader - Quality Control - Wockhardt Ltd.
(2012-10 - 2014-11)
USFDA, MHRA, TGA, ANVISA, WHO-Geneva Approved.
- Monitored raw-material sampling and analysis of API/excipients, vendor validation, and sample-pack validation.
- Managed sampling and analysis of packaging materials; headed the stability section and analysis of stability products per ICH guidelines.
- Directed analysis of starting materials, finished dosages
