Grace Chen Email & Phone Number

St. Louis, Mo, Us

Auckland, Nz

Auckland, New Zealand

16 Charann Place, Avondale, Auckland

To ensure Phytomed products are fit for purpose and consistent, meeting both external and internal requirements. This includes legal compliance and customer expectations.To lead, manage and participate in the Quality Assurance and Quality Control activities of the business.To be Phytomed’s responsible person on GMP and other externally certified quality certificates.

7 Pavilion Drive, Māngere, Auckland

• Evaluation of new raw materials for compliance and suitability for a range of markets, including NZ, AU, USA, China, Korea, Singapore, etc.• Development of regulatory compliant formulas and specifications across a range of markets.• Product optimisation and process improvement. • Providing compliant technical and regulatory information as required to satisfy the demands of customers and other external stakeholders.• Sensory development of formulas to achieve acceptable formulas for customers and consumers.• Generation and management of packaging, nutrition, allergen information, and other required information.• Recommending and sourcing appropriate packaging solutions for new and current products• Product label review.

Auckland, New Zealand

Company Background: A functional food manufacturer in New Zealand. Product lines include Infant Formula products and dietary supplements (soft gel, capsule, tablet, sachet). Commenced as an R&D Manager and Regulatory Manager.In 2020, added the role of Quality Manager Responsibilities:Regulatory• Product registration/filing according to the requirements of foreign countries.• Regulatory compliance with GMP, FSANZ, TGA, and GB.• Product label compliance.• Claim substantiation.• Import and export support.R&D • Implement and monitor research and development policies, strategies, and plans.• New product development from concept to launch: formulation, manufacturing process, trial, strength and stability testing. • Establish specifications for raw materials, packaging materials, bulk products, and finished products.• Production equipment qualification, manufacturing process validation/verification.Quality• Maintenance and review of the Quality System with adherence to RMP, NP, HACCP, and GMP.• Lead internal audits, host external audits, and follow up on non-conformance corrective actions.• Change control and the related validation.• Monitor and evaluate internal production processes and product quality.Major Achievements:• Acquired RMP certification for animal and non-animal production as a key team member.• Developed and launched 20 plus new products with probiotic powder being one of the best-selling products.• Improved the formula and manufacturing process of soft gel shell to make it chewable, tasty, and non-sticky.

Auckland, New Zealand

Graduate Teaching AssistantTutoring for two courses, FOODSCI 201: Foundations of Food Science and FOODSCI 303: Sensory Science

Guangzhou, Guangdong, China

Company Background: A global leader in healthy food industry. Commenced as a Senior QA Supervisor and then was promoted to an Assistant QA Manager.In 2014, promoted to be a Technical Regulatory Manager.Responsibilities:• Monitor food related legislation, identify regulatory risks, and provide solutions to support company business.• New product registration• Host the external audit of GMP, ISO 22000 and ISO 9001.• New product development. • Import and export support.• Supplier management.Major Achievements:Was granted an Excellence Award by USA headquarters for developing a new sports drink product.

Guangzhou, Guangdong, China

Company Background: A global leader in the medical device industry. The main products of Baxter cover large-volume injections and medical devices.QA SupervisorResponsibilities:• Product process development for a new product.• Manufacturing process validation.• Change control and related validation/verification, deviation, and batch document review.Major Achievements:Established a Quality Management System integrated from GMP, ISO 13485, ISO9001, 21CFR820, and the local regulatory requirements as a key member.

Guangzhou, Guangdong, China

Company Background: A government testing lab affiliated to Food and Drug Administration (FDA); a third-party testing lab. Pharmacist-in-chargeResponsibilities:• GMP auditing of pharmaceutical manufacturers.• Internal audit against ISO 17025.• Review of new medicine applications, particularly analytical methods, stability, and quality control. • Instrument analysis (HPLC, GC, MS).

Wuhan, Hubei, China

• Preparation of internal products including oral liquids, capsules, injections etc• Quality control for the raw materials, in-process and finished products• Dispensary

Doctor Of Philosophy - Phd, Chemistry

Master Of Business Administration - Mba

Master'S Degree, Medicinal And Pharmaceutical Chemistry

Bachelor'S Degree, Tradition Chinese Medicine