Mahmood Raza
Qa Compliance Specialist @Dechra
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WORK HISTORY
Qa Compliance Specialist @Dechra
Skipton, GB
Develop systems related to compliance activities to maximise quality and efficiency.• Performing line managing duties. Compliance associates and compliance admin staff.• Conduct internal audits and QA walkthroughs in order to verify compliance with the principles of GMP.• Support the QA Compliance Manager in preparation of hosting external (customers, regulatory authorities) audits• Preparation and regular review of Standard Operating Procedures relating to own areas of responsibility.• Contribute to the continuous development and improvement of relevant Quality systems, processes and procedures.• Monitor regulatory and Group requirements and assist in ensuring the site adapts to any changes.• Enforce compliance within the facility by ensuring staff consistently follow all compliance related procedures and by performing or ensuring the necessary investigations as and when deviations occur.• Ensure the management of systems for the recording, investigation and response to deviations, customer quality complaints and product recalls. • Provide Quality subject matter expert support on deviations, complaints and change controls within the incoming area ensuring proper root cause analysis, impact assessment and CAPA.• Work with area managers to ensure that actions required identified through internal audits, complaints, quality incidents and deviation investigation are properly addressed through effective CAPAs.• Participate and assist in external audits by customers and Regulatory Authorities as required and support the resolution of any audit deficiencies in a timely manner.• To perform regulatory gap assessments and drive QMS changes to ensure compliance.• Apply problem solving capabilities to determine root causes of issues and identify effective CAPA to increase right first time and improve efficiency and reduce operating cost.• Supporting the QA Compliance Manager to enable effective implementation of the GMP and GDP to meet regulatory compliance.
EDUCATION
Baqai Medical University
Doctor of Pharmacy (Pharm.D.), Pharmaceutical Sciences
SKILLS
ABOUT MAHMOOD RAZA
Accomplished, focused & disciplined Pharmacist with more than 14 years of experience reflecting Highly Qualified and Experienced Pharmaceutical Scientist, experienced in:• Leading implementation of eQMS and ERP system along with training out to site.•Got advanced training on GMP, DI, essentials for hiring, leadership, IOSH, advance training on QMS and Employment relations and the latest good practice for employers.•Regulatory Requirements and Expectations,(c)GMP and GLP and GDP.• Good understating of the UK, EU, US, JP, CA & NZ/AU regulatory channels• Good understating of the product dossier (CTD, CPID, NDA model etc) • Good understanding of ICH, Eudralex, MHRA, VMD and Pharmacopoeia guidelines (Ph Eur/BP/USP)• Experienced in enhancing and refining the procedures associated with the components of the PQS.• Managing Deviations, variations, CAPA, change controls, Risk Assessments, recalls and complaints• Quality documents.i.e. Protocols, Risk Assessment, CQTAs & PQRs etc review/generation• Experienced in leading the internal audits• Batch (Specials) review for market release• Mini QP Training.• Managing and maintaining raw material/product stock• Comfortable working extended hours to produce tangible results.• Enthusiastic, Adaptive and Fast-Learning person with a broad and acute interest in the Discovery of New Innovative Drugs• Administratively self-sufficient (Microsoft Office Suite) achievement • Honest, loyal and devoted to my work.• Good communication skills, written, spoken and presentation
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