Mary Nguyen
Head Of Quality at PharmaPac- Claim this Profile
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Bio
Experience
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PharmaPac
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United Kingdom
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Head Of Quality
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Aug 2022 - Present
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Ransom Naturals Ltd
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United Kingdom
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Head Of Quality
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May 2018 - Aug 2022
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Barts Health NHS Trust
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United Kingdom
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Hospitals and Health Care
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700 & Above Employee
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Head Of Quality
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Jun 2017 - Apr 2018
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Deputy Head of Quality
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Apr 2016 - Jun 2017
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QA Manager
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Oct 2015 - Apr 2016
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Guy's and St Thomas' NHS Foundation Trust
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United Kingdom
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Hospitals and Health Care
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700 & Above Employee
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Quality Control Laboratory Manager
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Mar 2015 - Oct 2015
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Laboratory Operations Manager, Interim
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Sep 2014 - Mar 2015
* Direct and control the Quality Control team activity in line with Operational GxP, MHRA and Regulatory requirements.* Manage the team workload in conjunction with relevant team leaders and management utilising tools such as capacity planning and fortnightly forecasting. Workload to coordinate includes routine testing, method optimisation and validation, stability testing, raw materials, production requests and maintenance requirements.* Instruct lab staff on QC competencies to ensure they are trained to a suitable level, including work experience students and rotational staff.* Assess capability of processes to ensure they are suitable to receive, disposition and book raw materials, intermediates and in-process materials.* Coordinate the review and verification of all raw data and analytical reports generated by the QC Lab to meet cGMP requirements.* Construct and review technical documentation including procedures, methods, specifications, and related documents.* Generate and monitor quality documentation including planned batch changes, change controls, quality exception reports and preventative and correction actions.* Investigate OOS/OOT and create action plans where necessary.* Undertake projects and specific responsibilities as required by Head of Quality Control Show less
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QC Analyst
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Mar 2014 - Sep 2014
Quality Control AnalystTechnical* Analytical project leader for various method development and method verification projects.* Method development/verification/validation of methods for stability testing, routine release testing and transfer into the QC department to MHRA/BP/EP and USP standards.* Write and review method verification protocols, stability protocols, shelf-life justification documents.* Write and review SOPs for new processes within the laboratory.
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Moorfields Pharmaceuticals
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London, United Kingdom
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Analytical Development Chemist
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May 2013 - Mar 2014
Technical * Analytical project leader for various method development and method verification projects. * Method development/verification/validation of methods for stability testing, routine release testing and transfer into the QC department to MHRA/BP/EP and USP standards. * Write and review method verification protocols, stability protocols, shelf-life justification documents. * Write and review SOPs for new processes within the laboratory. Other: * Health and safety representative for the quality laboratories. * 5S team member, leading various initiatives. Show less
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Sun Chemical
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United States
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Chemical Manufacturing
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700 & Above Employee
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Analytical Chemist/Dep. H&S Representative
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Jun 2007 - May 2013
Technical • Project leader of various method development and validation projects. Liaising with national / international divisions for support and information exchange. • Team leader of the migration testing team: analysis of extractables and leachables into food simulants in accordance to EU legislation (Directive 10/2011, Swiss Ordinance) using GC-MS / HPLC-UV-MS. • Team leader of high through-put QC testing - qualitative and quantitative by GC-MS. • Primary point of contact for analysis of samples by rheological, surface science, and thermal analysis techniques. Support other analysts with complimentary techniques: FTIR / UV-Vis spectroscopy. • Method development for short lead-time customer requests. Quality and safety • Health and safety coordinator for the technical departments including coordination of regular safety audits, representing the technical departments in site safety meetings. • Key contact for risk and COSHH assessments maintained via the Quality Manual and RisQ program. • Internal ISO (17025 / 9001) auditor for the Analytical services department, including method competency audits; and the manufacturing site. Show less
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Procter & Gamble
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United States
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Manufacturing
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700 & Above Employee
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Formulation & Process Development Chemist
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Aug 2006 - Jul 2007
Tasks/Responsibilities: • Develop and modify product formulations for the Vicks Throat Drop and indulgent gummy range following GMP standards. Perform analysis on the new / reformulated prototypes. • Co-ordinate with Analytical, QA and Safety support functions to develop and validate new methods required for in-process and stability analysis of developed / modified formulations and ensure they are compliant to global requirements for human consumption. Tasks/Responsibilities: • Develop and modify product formulations for the Vicks Throat Drop and indulgent gummy range following GMP standards. Perform analysis on the new / reformulated prototypes. • Co-ordinate with Analytical, QA and Safety support functions to develop and validate new methods required for in-process and stability analysis of developed / modified formulations and ensure they are compliant to global requirements for human consumption.
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Air Liquide
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France
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Chemical Manufacturing
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700 & Above Employee
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Laboratory Supervisor, Specialty Gases
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Apr 2004 - Jul 2007
Technical • Accountable for the operations of the Speciality Gases Laboratory and on-site sulphur dioxide plant. Supervised and directed a small team of chemists / plant operators to ensure timely production, certification and dispatch of products. • Logistics coordinator for raw material receipt and dispatch of products between Australia, Europe, Asia, Melanesia and the Americas. • Key contact for technical support to world-wide customers, sales representatives and other laboratories. • One of two people in Australia authorised by the company to manufacture toxic/reactive gas blends and oxidant-fuel mixtures. • Primary figure responsible for the composition of gas mixture batch cards. • Responsible for the sourcing of all raw materials and standards for the lab and the management of intermediates. Quality and Safety • Maintain own and laboratory’s accreditation with NATA as well as the company’s quality system. • Facilitate compliance to TGA (Therapeutic Goods Administration), EP (European Pharmocopeia) and ISO(17025 / 9001 / 9002) standards. Show less
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Education
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University of Wollongong
Bachelor of Science, Biochemistry -
APMG-International
Prince2 Foundation -
Harrington Morgan
IOSH Managing Safely -
London South Bank University
Diploma in Management Studies -
King's College London
Radiopharmaceutical QC techniques, Pharmaceutical Sciences -
King's College London
Postgraduate Radiopharmacy Course -
The London School of Economics and Political Science (LSE)
MBA Essentials Certificate, Business Administration and Management, General