Antony Andrews
Global Quality Compliance Manager @Reckitt
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WORK HISTORY
Global Quality Compliance Manager @Reckitt
Hull, GB
As Global Quality Compliance Manager at Reckitt, I lead strategic compliance initiatives across global GxP systems, ensuring alignment with regulatory standards and internal quality frameworks. My role encompasses ownership of global Computerised System Validation (CSV) policies and associated Quality Management Systems (QMS), with a focus on continuous improvement and audit readiness.Key Responsibilities:* Oversee compliance for global GxP applications, including AI apps, Veeva, PLM & SAP.* Serve as Quality System Owner for key Regulatory, Supply, and R&D systems.* Global deployment of CSA methodology as Project Lead.* Represent Systems during regulatory audits (FDA, MHRA, ANVISA) and internal inspections.* Coach and mentor cross-functional teams and vendors on compliance standards.* Drive enhancements in CSV, Data Integrity, and Validation practices.
EDUCATION
Mahatma Gandhi University
Bachelors, Electronics and Communication
Sheffield Hallam University
Masters, Networking Professional
SKILLS
ABOUT ANTONY ANDREWS
A passionate, enthusiastic and committed Engineering/Quality professional with hands on experience in Validation, Quality Assurance/ QMS, CSV, CSA, Project management & Auditing.Over 14 years Pharma experience | Qualification & Validation | Equipment Validation I CSV & Data Integrity SME | Computerised System Validation | CSA I Auditing- 10+ years of experience in in Pharma covering Engineering, Technical & Quality departments- Held senior roles/ Experienced/ SME in Validation (Equipment/ Computerised system)- Experienced in hosting External Audits (MHRA, FDA, ANVISA, ISO etc)- Experienced as an Auditor (Internal & Supplier)- Experienced in setting up strategies, policies, procedures & templates for QMS/Validation/CSV- Good understanding of IT & Quality compliance within Pharma- Risk Management Process, Change & Incident Management, Data Integrity, CAPA, FMEA etc- Good understanding of Regulatory standards (21 CFR Part 11, GAMP5, GPGs, EU GMP Annex, CSA etc)- Led teams and managed complex projects as per business needs- Proficiency in QMS tools, Automation tools and few other Industry leading applications enabling innovations.Other skills: Mentoring junior Engineers into basics of Validation I Management & Coordination of Quality, Testing, Validation, Compliance and Commissioning activities in Pharmaceutical Industries. Full validation lifecycle activities with efficient project and test planning, providing satisfactory reports. GxP, GAMP5, including VMP, IQ, OQ, PQ, DQ, RA, IA, FRS, URS, VS, RTM/TM I UT,ST, SIT, UAT, Use cases, Gap analysis, Root Cause, Deviations, Defects / Non Conformances, SOP\'s, CAPA\'s, ERES, DIs etc.
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