Caroline Tsang

Quality Assurance Consultant Contract Qp @Qualipharm Consultancy Ltd

Edinburgh, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2014 — Present

Quality Assurance Consultant Contract Qp @Qualipharm Consultancy Ltd

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Edinburgh, GB

Quality Assurance ConsultantServices include- Contract QP services- Contract RP & RPi services- Quality Assurance - Interim Quality Management- Quality Auditing- QMS Design & Implementation- Interim Microbiology Laboratory Management- Microbiology Consultancy services- Trainee QP Mentoring

EDUCATION

2019 — 2019

BSI Training Academy

Diploma, Quality Management Systems

1990 — 1994

Sheffield Hallam University

BSc (Hons), Biomedical Technology

2004 — 2006

University of Brighton

PG Dip, Industrial Pharmaceutical Studies

2011 — 2012

University of Brighton

Master of Science (MSc), Industrial Pharmaceutical Studies

SKILLS

Change ControlQuality AuditingClinical TrialsPharmaceutical MicrobiologyQuality SystemQuality SystemsQuality AssuranceQualified PersonPharmaceutical IndustrySopCapaContract QpGmpQp CertificationPharmaceutical Management SystemsMicrobiologyQmsGdpQuality ManagementDeviationsQpMhraValidationQualityAuditorInterim Quality ManagementPharmaceuticalsGlpAuditing

ABOUT CAROLINE TSANG

I am a Quality Assurance Consultant with over 30 years experience in pharmaceuticals. My work at QualiPharm Consultancy provides clients with assistance to assure quality and compliance of their systems and products.I am a Qualified Person (under Permanent Provisions) for Commercial and Investigational Medicinal Products. I have been named on licences and working as an active QP since 2004. I specialise in solid dose, liquids and steriles including biologics, ATMPs and radiopharmaceuticals. I offer contract / interim QP services to manufacturing authorisation holders in UK, Ireland and the rest of the EU.I help clients with the operation and management of their Quality Management Systems from the design and implementation of a new QMS through to routine operation and maintenance of existing quality systems.I have knowledge and experience of managing and supervising Quality Assurance departments from managing teams of laboratory technicians to supervising a team of QPs.As an auditor, I can assist clients with their auditing requirements as I have conducted internal, supplier and QP audits for compliance with GMP, GLP and GDP in the UK and overseas. The range of audits I have experience in include API manufacturers, drug product manufacturers, packaging facilities, contract testing laboratories (QC, microbiology & toxicology), wholesale dealers, warehouses, packaging suppliers.I have a background in Pharmaceutical Microbiology including management of microbiology laboratories for a biopharmaceutical company and can provide interim solutions for Microbiology laboratory Management.I can help with all aspects of Pharmaceutical Quality Assurance so if you would like to discuss your company’s quality requirements, please contact me-email: c•••••••@qualipharm.co.uk-

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Caroline Tsang — Quality Assurance Consultant Contract Qp at Qualipharm Consultancy Ltd in Edinburgh, GB | Unifers