Anil Minhas
City West,Ireland
Summary
Accomplished professional with extensive expertise in department management, facility management, and regulatory compliance. Proven track record in contract management, quality assurance, and compliance oversight. Demonstrates exceptional leadership skills and proficiency in contract negotiation. Committed to driving organisational success through strategic planning and operational excellence.
Overview
24
24
years of professional experience
2
2
years of post-secondary education
1
1
Certification
Work History
External Supply Quality Operations Lead (EU)
Pfizer
Marlow, Buckinghamshire
10.2016 - 03.2025
- 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
- Review and approve master batch records, process validation protocols and reports, and support analytical method transfers
- 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(Pfizer)
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, UK
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 injectable 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
- 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
Dr. Reddy's Laboratories Ltd
12.2006 - 02.2011
- Conducted schedule audits of the Sterile and Non- sterile Formulations (Oral Solid Dosage, Injectable, 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 (Audit and Compliance)
Aurobindo Pharma Ltd.
12.2004 - 12.2006
In -Process Quality Control
Dr. Reddy's Laboratories Ltd
09.2003 - 12.2004
In -Process Quality Control
Panacea biotec
01.2001 - 09.2003
Education
Master of Science - Industrial Pharmaceutical Science
Atlantic Technological University
Ireland 09.2022 - 10.2024
Master of Science - Chemistry
Rohilkhand University
IndiaMaster of Science - Total Quality Management
Lucknow University
IndiaBachelor of Science - Biological sciences
Panjab University
IndiaSkills
- Department management
- Facility management
- Regulatory compliance
- Contract management
- Quality Assurance
- Leadership skills
- Compliance oversight
- Contract negotiation
Affiliations
- Travelling and making connections
- Playing Tennis
- Public Speaking
Accomplishments
- Led successful regulatory inspections by MHRA, US FDA, ANVISA, and WHO at multiple sites with minimal observations.
- Recognised by senior leadership at Pfizer for exceptional audit readiness and quality compliance support across EU contract manufacturing sites.
- Awarded “Best Compliance Contributor” for streamlining QMS processes and reducing deviation closure timelines by 30%.
- Key contributor to product launch teams , supporting timely batch release and validation reviews for high-priority commercial products.
- Developed and implemented a supplier risk dashboard , improving risk visibility and helping reduce supplier-related complaints .
- Played a pivotal role in achieving ISO/GMP certification for new or expanded manufacturing facilities (if applicable).
- Mentored junior QA staff and cross-functional teams in GMP, audit readiness, and CAPA systems, improving team audit performance.
Certification
- Pharma QMS -IRCA Certified Lead auditor
- Eligible Qualified Person
Languages
English
Fluent
Hindi
Fluent
Punjabi
Fluent
Timeline
Master of Science - Industrial Pharmaceutical Science
Atlantic Technological University
09.2022 - 10.2024
External Supply Quality Operations Lead (EU)
Pfizer
10.2016 - 03.2025
Senior Quality Compliance Auditor
Hospira Ltd(Pfizer)
08.2015 - 09.2016
Quality Assurance - Asst. Manager, UK
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
Dr. Reddy's Laboratories Ltd
12.2006 - 02.2011
Assistant Manager- QA (Audit and Compliance)
Aurobindo Pharma Ltd.
12.2004 - 12.2006
In -Process Quality Control
Dr. Reddy's Laboratories Ltd
09.2003 - 12.2004
In -Process Quality Control
Panacea biotec
01.2001 - 09.2003
Master of Science - Chemistry
Rohilkhand University
Master of Science - Total Quality Management
Lucknow University
Bachelor of Science - Biological sciences
Panjab University
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