Anil Minhas
Summary
- IRCA certified Pharmaceutical QMS lead auditor (renewal pending)
- Strong analytical and investigative skills
Overview
24
24
years of professional experience
Work History
External Supply Quality Manager
Pfizer Ltd
10.2016 - Current
- Liaising with the Qualified Person (QP) for products manufactured at EU contract manufacturing sites, ensuring compliance with the Marketing Authorisations
- Leading and supporting cGMP projects for continuous improvement, ensuring compliance with regulations and current industry standards, offering support to operations and the regulatory teams during new product launches
- Assisting the corporate audit team to perform quality audits of contractors and suppliers to ensure products, controls, procedures, and processes meet Pfizer quality standards
- Providing crucial support to contract manufacturing and testing sites to ensure audit readiness in preparation for health authority inspections
- Conducting annual technical visits to contractor sites, prioritising based on overall risk assessments, and preparing comprehensive reports
- Communicating findings to both external and internal stakeholders
- Managing contractor deviations and ensuring the implementation of adequate CAPAs using Veeva eQMS systems
- Managing contractor change controls and ensuring its implementation using Trackwise system
- Supporting Out of Specification (OOS) and Out of Trend (OOT) investigations, including approval, and ensuring the implementation of appropriate CAPAs
- Providing support for market complaints, including those originating from the warehouse, and ensuring thorough investigation and statistical analysis to minimise repeat complaints
- Management of quality agreements with contract manufacturing sites, and contract testing laboratories, ensuring compliance with GxP requirements and clear delineation of responsibilities
- Conducting and summarising the comprehensive annual product quality review for Pfizer-supplied products
- Monitoring contract manufacturers performance by preparing a monthly risk dashboard to assess and track overall risk levels
- Acting as the central point of contact, facilitating effective communication among team members, and ensuring alignment with project goals and timelines.
Senior Quality Compliance Auditor
Hospira Ltd
08.2015 - 09.2016
- Conducted comprehensive audits of contract manufacturing sites for various product categories, including sterile products, non-sterile products (e.g., oral solid dosage formulations, ointments, creams, and medical devices), as well as Quality Control (QC) testing laboratories, packaging sites, and warehouses
- The audits were conducted in strict accordance with GXP guidelines and Pfizer quality standards, with a focus on ensuring the timely completion of proposed Corrective and Preventive Actions (CAPAs).
Quality Assurance -Asst. Manager
Auden Mckenzie (Pharma division) Ltd, Actavis Group
11.2011 - 08.2015
- Sterile and Non-sterile Formulations), Review of batch records and quality control data in line with the Marketing Authorisations and preparation for product release by the Qualified Person (QP) for in-house manufactured terminal sterilised injectables and third country imported solid oral dosage formulations;
- Liaising with Qualified Person (QP) for products being manufactured in EU contract manufacturing sites confirming their compliance with the Marketing Authorisations
- Interacting with the Regulatory Affairs department regarding the notification and approval of variations to the Marketing Authorisations and notifying the updates to the QP
- Quality Assurance activities related to wholesale distribution of our pharmaceutical products according to EU-GDP, legislations, and guidelines in force
- Authoring and reviewing Standard Operating Procedures based on the routine practices in QMS
- Review and approval of the process validation and cleaning validation documents
- Management of Technical Agreements between Auden Mckenzie and third-party manufacturing and testing sites by ensuring compliance with regulatory requirements
- Assisting the QP during audit of contract manufacturers in UK and Europe
- Provide support in preparation and hosting of MHRA inspection
- Authoring and issuing self-inspection programme and conducting self-inspections of manufacturing, warehouse, regulatory affairs (GMP, GDP and GPV)
- Maintaining and implementing Quality Management Systems including CAPA, Deviation, Market complaints, Change Control & Risk assessment
- Facilitate Customer complaint investigation and reporting with reference to suppliers and contractors
- Co-ordinate PQR report collection from contractors/3rd party facilities
- Perform appropriate PQR data review and reporting for suppliers and contractors.
Senior Quality Manager
Fresenius Kabi Oncology Ltd
02.2011 - 10.2011
- Fresenius-kabi-oncology.com, Responsibilities:
- Review of QC analytical reports, including HPLC chromatograms, batch records and batch certification in line with the Marketing Authorisations for in-house manufactured parenteral products and solid oral dosage formulations;
- Perform API supplier audits as needed
- Management of QMS (Change control, Deviation by risk assessment tool)
- Responsible for CAPA system including procedures, tracking completion and effectiveness
- Responsible for complaint handling and its investigation
- Review and approval of Cleaning validation, Process validation reports, IQ, OQ and PQ of equipment’s, HVAC and water system
- Schedule medial fill according to the validation plan, review and approve the final report upon completion of the aseptic media Fill (Process Simulation Study)
- Prepare annual audit plan and conduct Internal audits
- Stability protocol and reports review, Analytical method Transfer and Product Transfer report review and approval
- Assist all departments in preparing for regulatory inspection (UK MHRA, US FDA, INVIMA), prepare the responses to audit observations and follow-up actions.
QA - Audit & Compliance Manager
Reddy’s Laboratories Ltd
12.2006 - 02.2011
- Sterile and Non- sterile Formulations)
- Conducted schedule audits of the Dr
- Reddy’s own manufacturing sites(Oral Solid Dosage, Injectables, Ointment’s ,Liquid Oral),API units as per the respective regulatory guidelines and CRO(Clinical Research Organization) qualification as per the ICH GCP guidelines
- Assist in preparing for the regulatory inspections (US FDA, MHRA, ANVISA ), prepare the responses and follow-up actions
- Review and approval of Quality Management System (SMF, Quality Manual ;Validation Master Plan; Change control ;Market complaints etc.)
- Review of the PDR (Product Development Report), Exhibit/Pilot batches and Process validation reports
- Training manufacturing/ QA on specific topic to improve Efficiency of Regulatory Compliance
Assistant Manager- QA
AUROBINDO PHARMA LTD
12.2004 - 12.2006
- Non -sterile drug products)
- Assist in preparing for regulatory audits (US FDA, MHRA, Health Canada), prepared the response and follow-up actions
- Review and approval of Cleaning validation protocol and report, Process validation protocol and reports, IQ, OQ and PQ of equipment’s
- Conducted internal audits as per the Published schedule and ensured appropriate corrective and preventive actions to internal audits
- Perform final QA review and provide final dispositions for investigations, deviations, change controls and Market Complaints.
Reddy’s Laboratories Ltd
09.2003 - 12.2004
- In -Process Quality Control (Sterile and non -sterile drug products), Line clearance and in-process control for manufacturing and Packing activities of sterile injectable products; liquid orals and solid dosage form
- To review the QC analytical reports, including HPLC chromatograms, medial fill reports, batch manufacturing, packaging records and associated documents (deviations, change controls) to ensure compliance before batch release, in accordance with GMP standards before QA release
- Sampling of the filled ampoules and vials for AQL inspection, sampling and testing of the equipment’s cleaning samples, annual review of the finished product reference samples.
biotec.com
01.2001 - 09.2003
- Line clearance before manufacturing and packing activities of liquid orals; semi-solids and solid oral dosage form
- Perform In-Process Quality control test during drug product manufacturing activities
- Bulk sampling and testing of Solid Oral Products (moisture content of granules, weight variation, hardness, thickness, friability, disintegration and weight gain during coating.); Liquid orals (pH, specific gravity, fill volume) ; semi solids (viscosity; pH )
- QC sampling of the raw materials and primary packaging material FTIR testing ; printed aluminum blister foil grammage test , VMCH coating .
Quality Control officer
PANACEA BIOTEC LTD
- Non-sterile drug products
Education
M.Sc - Industrial Pharmaceutical Science
Atlantic Technological University
IrelandQ3P Qualified Person modules -
UCL School of Pharmacy
London2018
Pharmaceutical QMS Lead Auditor Course, Inspired Pharma UK - undefined
2012
Member of Royal Society of ChemistryIRCA Certified Lead Auditor (Pharmaceutical QMS) - undefined
2008
M. TQM - Total Quality Management
Lucknow University
2000
M.Sc. - Chemistry
Rohilkhand University
B.Sc - Chemistry, Botany & Zoology
Panjab University
Timeline
External Supply Quality Manager
Pfizer Ltd
10.2016 - Current
Senior Quality Compliance Auditor
Hospira Ltd
08.2015 - 09.2016
Quality Assurance -Asst. Manager
Auden Mckenzie (Pharma division) Ltd, Actavis Group
11.2011 - 08.2015
Senior Quality Manager
Fresenius Kabi Oncology Ltd
02.2011 - 10.2011
QA - Audit & Compliance Manager
Reddy’s Laboratories Ltd
12.2006 - 02.2011
Assistant Manager- QA
AUROBINDO PHARMA LTD
12.2004 - 12.2006
Reddy’s Laboratories Ltd
09.2003 - 12.2004
biotec.com
01.2001 - 09.2003
Quality Control officer
PANACEA BIOTEC LTD
Pharmaceutical QMS Lead Auditor Course, Inspired Pharma UK - undefined
Member of Royal Society of ChemistryIRCA Certified Lead Auditor (Pharmaceutical QMS) - undefined
M. TQM - Total Quality Management
Lucknow University
M.Sc. - Chemistry
Rohilkhand University
B.Sc - Chemistry, Botany & Zoology
Panjab University
M.Sc - Industrial Pharmaceutical Science
Atlantic Technological University
Q3P Qualified Person modules -
UCL School of Pharmacy