EXPERIENCE IN THERAPEUTIC PRODUCTS INDUSTRYFormulation Development and Production• In depth understanding of Natural Health Product Manufacturing• Review of Batch Manufacturing Records• Review of Master Packaging Records• Liaison for Production staff programsQuality Assurance and Regulatory Affairs• Company Liaison during Site Audits• cGMP Documentation Auditing• Process SOPs• Validation Protocols• Product Quality SOPs• Preparation of pre-inspection plan during customer site audits• Preparation and filing of “Natural Health Products – Product License Application”• Fair knowledge on Electronic Common Technical Document (eCTD) format filing with Regulatory Agencies
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Regulatory SpecialistCosmaceutical Research Lab Inc Jan 2023 - Mar 2023Surrey, British Columbia, Canada• Acted to ensure regulatory requirements are met during product development• Kept abreast with current US and Canadian regulations, guidance, and standards applicable to company product• Developing and writing new Standard Operating Procedures (SOPs) and updating existing ones -
Health And Safety Coordinator/Qa AssociateAccurex Health Care Manufacturing Inc 2014 - Oct 2021Canada• Conducting Quality Assurance Inspections- Internal Audits • Developing and writing new Standard Operating Procedures (SOPs) and updating existing ones• Health and Safety training for new and existing employees• Developing and implementing health and safety standards and procedures• In conjunction with senior management, reviewing/revising the company’s health and safety program annually• Conduct annual audits of the company’s Health and Safety program -
Regulatory Affairs/Health & Safety CoordinatorAccurex Health Care Manufacturing Inc Jul 2009 - Dec 2013BrantfordMy Responsibilities Included• Applying for and obtaining new Product Licenses from Health Canada• Preparing and submitting notifications and amendments for existing Product Licenses• Applying for and obtaining the company’s site license on four separate occasions• Forming a part of the teams that meets with auditors/inspectors for GMP as well as for Health and Safety purposes• Conducting cGMP and Health and Safety training for new and existing employees
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Qa/Qc AssistantAccurex Health Care Manufacturing Inc Jul 2006 - Jun 2009Brantford• Developing and writing new Standard Operating Procedures (SOPs) and updating existing ones• Reviewing of completed Batch Manufacturing Records and Master Packaging Records • Release of packaging and labelling materials
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Resource Mobilization ManagerOpportunities Industrialisation Centres Feb 2003 - Mar 2005Accra, Ghana• Wrote proposals to donors for fundraising purposes. • Managed the affairs of a Counseling Consultancy Unit, which included supervision of counselors and scheduling appointments with clients. • HIV / AIDS Coordinator at the Head Office level, which involved organizing workshops to train counselors for HIV / AIDS Projects, and monitoring the projects at the three OIC Ghana Training centers. • Supervised Resource Mobilization Officers (RMOs) at the three orc Ghana Training centers. Organized workshops to train RMOs in topics such as Effective Proposal Writing, Fundraising Strategies, Target Setting; and facilitated some of the sessions. • Wrote articles for the "Opportunity News" a newsletter for OIC, Intemational- Ghana.
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Assistant Research OfficerGhana Atomic Energy Commission Sep 2001 - Aug 2002Accra, Ghana• Worked with the neutron activation analysis group at the Reactor Center. Analyzed geological, biological, and metal samples both quantitatively and qualitatively.
Mary Duncan Skills
Mary Duncan Education Details
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Chemical Engineering -
Aburi Girls High School
Frequently Asked Questions about Mary Duncan
What is Mary Duncan's role at the current company?
Mary Duncan's current role is Regulatory Specialist.
What schools did Mary Duncan attend?
Mary Duncan attended Kwame Nkrumah University Of Science And Technology, Kumasi, Aburi Girls High School.
What skills is Mary Duncan known for?
Mary Duncan has skills like Experience In Therapeutic Products Industry, Quality Assurance, Sop, Gmp, Validation, Regulatory Affairs, Manufacturing, Inspection, Auditing, Formulation, Materials.
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Mary Jo Y.
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