Responsible Person for Import (RPI)/Quality Assurance Manager - Aimmune Therapeutics (Nestle UK)
(2023-10 - 2025-12)
- Act as RP/RPI for imports and exports for Nestle UK (Aimmune Therapeutics Ltd)
- RP/RPI on 2 WDA Licences
- Ensuring that medicinal products have been QP released in accordance with Article 51 of Directive 2001/83/EC
- Completing supply chain checks to ensure the batch is not subject to recall or reported as stolen and is available on the market in the listed country's licensed supply chain
- Confirming the status of unique identifiers for Prescription Only Medicines (per Commission Delegated Regulation EU 2016/161) if required for parallel import, special clinical need or for introduction
- Ensuring that any additional requirements imposed on certain products by national law are adhered to
- Implement and maintain a robust QMS for Nestle UK (Aimmune Therapeutics Ltd.)
GMP/GDP Consultant - KD Pharma
(2022-01 - 2023-09)
- Develop and implement GMP QMS for the site
- Develop, manage and prepare the site for GMP Inspection Readiness
- Promote awareness of regulatory and QMS requirements throughout the team
- Develop a quality culture across the site
- Provide GMP and GDP training to the staff
- Work directly with CMOs on inspection readiness activities, including identification of potential inspection risks
Responsible Person (Consultant) - Pharmacy World Limited
(2021-01 - 2021-12)
- Review the MHRA post-inspection report with the client, addressing each non-conformity, deciding the best corrective actions and realistic timelines for putting the actions into place
- Carry out a full gap analysis of the client's quality system and activities against the GDP Guidelines
- Help the client establish an updated Quality System that meets the requirements
- Provided RP support and helped with the suspended WDA(H) licence return to full GDP compliance
Operational Quality Manager - UK Health Security Agency (UKHSA)
(2020-09 - 2021-02)
- Support with the management of GMP/GDP and ISO13485 quality system
- Oversee all GMP-related and QMS activities on a day-to-day basis including training, audits, validation, processes, product, SOPs, deviations, CAPAs etc
- Maintaining compliance of PCR and LFT kits to ISO13485
- Ensuring end-to-end kitting is operated to all approved work instructions and required documentation is completed in full
- Develop a system for reporting product performance data to identify trends and evidence conformity, liaising with the central quality team
- Develop and manage key performance indicators (KPIs) to increase and monitor the performance of the department
- Promote awareness of regulatory and QMS requirements throughout the team
Responsible Person (Consultant) - Nompharma Limited
(2019-07)
- Building Quality Systems in compliance with GDP
- Acting as an external support network for an internal RP
- Acting on an ongoing basis as a contract RP
- Perform all Responsible Person Duties and Responsibilities
EU Quality Manager & Responsible Person (RP) - Piramal Critical Care (PCC)
(2016-08 - 2019-06)
- Overseeing and ensuring that a GMP quality management system is implemented and maintained
- Lead on the EMA, MHRA, FDA regulatory inspections and GMP compliance for all licence submissions including all correspondences with regulatory inspectors and auditors on behalf of PCC Limited
- Oversee all GMP-related and QMS activities on a day-to-day basis including trainings, audits, validation, processes, product, SOPs, deviations, CAPAs, etc
- Drafting and approving commercial and technical contracts /agreements
- Communicating with the Regulatory Agency on behalf of PCC Limited in relation to any GMP, GDP, Regulatory or administrative matters
- Ensuring that the self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
- Developed a Quality System to cover manufacturing and the wholesaling of medicines in compliance with GMP/GDP as evidenced by successful MHRA Inspections
- Successfully hosted 18 MHRA and 5 FDA inspections
- Successfully hosted Home Office inspection and obtained CD licence
- Successfully hosted 3 Dutch inspections and 5 EMA inspections
- Performed 30 Suppliers and 15 third-party logistics (3PL) audits
Quality Assurance Manager and Head of Quality Control - Nemaura Pharma Ltd, UK
(2014-03 - 2016-07)
- Ensure compliance with the company quality systems, IMP GMP requirements and all regulatory body requirements
- Supervise IMP batch release in compliance with EudraLex Vol. 4 in relation to the Investigational medicinal products (IMPs) manufactured and tested by the client
- Ensure the effective use and implementation of the QMS (training, procedures, quality issues, CAPA) across the company. Identify, communicate, and escalate quality and compliance risks
- Plan, direct and, as necessary, conduct internal & external compliance audits to assure compliance with company policies and procedures
- Monitor and trend any quality aspects pertaining to the facilities/equipment and Quality Management System in line with IMP GMP requirements - report findings at the Monthly Management Review meetings
- Maintain continuous personal development and maintain up-to-date knowledge of current and proposed pharmaceutical regulations
- Established a robust Quality Management System from scratch
- Successfully hosted MHRA inspection and obtained Manufacturer's/Importer's licence (MIA)
- Successfully hosted Home Office inspection and obtained CD licence
EMEA (Europe, Middle East & Africa) QUALITY Auditor - Hospira UK Limited
(2012-01 - 2014-02)
- Perform supplier and third-party manufacturer (TPM) audits- including follow-up and closeout
- Support the management of the EMEA Regional Supplier and Quality oversight programs
- Support the negotiation and execution of technical agreements
- Perform regular reviews of guidelines, regulations and laws associated with GxP compliance and determine the impact of these on company audit processes and procedures
- Performed 46 suppliers and 17 Third Party Logistics (3PL) audits
- Performed 20 self-inspections/audits
Quality Assurance Specialist (contract) - Eli Lilly LTD, Liverpool, UK
(2008-10 - 2012-12)
- Identify issues related to manufacturing or testing that may affect the quality, safety, purity, or efficacy of drug substances or products
- Conduct batch document review and archiving, including laboratory data, log sheets, logbooks, etc
- Support production and testing areas in the investigation and resolution of deviations and investigations
- Coordinate quality aspects of product technical transfers and other technical projects
Quality Assurance Manager - Novozymes Biopharma UK Limited (formerly Delta Biotech), Nottingham
(2005-04 - 2008-09)
- Responsible for the prompt resolution of all deviations arising from Novozymes manufacturing processes and supporting systems
- Management of Novozymes deviation systems(track-wise) and associated databases
- Managed corrective and preventive action plans (CAPAs) and ensured that follow-up and implementation of corrections were completed in line with the company's policies and procedures
Senior Compliance Officer/Auditor - Centocor (Johnson & Johnson company), Leiden, Holland
(2001-10 - 2005-03)
- Responsible for the assessment of the site compliance with regulatory (FDA/EU/MHRA) requirements and company policies/standards through a program of internal quality audits, and providing relevant feedback to site management
- Participated in 30 suppliers' quality audits and supported general quality assurance and compliance initiatives
- Co-ordinated 10 Dutch inspections and audits
- Co-ordinated 6 EMA inspections and audits
QA Officer - Synco Bio-partners, Amsterdam, Holland
(1998-11 - 2001-09)
- Review batch records to ensure that all steps have been performed and verified where applicable, that all limits and specifications have been met, and that the raw materials and solutions have been tested and released
- Support production and testing areas in the investigation and resolution of deviations and investigations
- Review technical reports, protocols, final reports, stability reports, and other forms of documentation as required
