QA/RA & Project Manager
บันทึกงานนี้และจัดระเบียบการค้นหาของคุณ
สร้างบัญชีฟรีเพื่อบันทึกงาน สร้างการแจ้งเตือน และกลับมาที่รายการนี้จากแดชบอร์ดของคุณ
Key responsibilities
Regulatory Affairs (RA)
- Product registrations: Manage and execute the registration and notification of dietary supplements with relevant health authorities (e.g., FDA, Halal, COA)
- Formula, Label & Claims Review: Review and approve product formula, packaging, labels, marketing materials, and websites to ensure compliance with health and nutrition claim regulations
- Regulatory Compliance: Monitor changes in food supplement regulations and communicate impacts to product development and supply chain teams
- Health Authority Liaison: Act as the primary point of contact for regulatory agencies, managing audits and submissions Quality Assurance (QA)
- QMS Oversight: Maintain, update, and enforce the company's Quality Management System in accordance with GMP (Good Manufacturing Practices) and HACCP standards
- Vendor & Manufacturer Audits: Audit third-party manufacturers (CMOs), raw material suppliers, and testing laboratories to ensure compliance with quality agreements
- Batch Record Review: Review and release finished product batch records, certificate of analysis (COAs), and stability test data
- Non-conformance & CAPA: Lead investigations into product deviations, out-of-specification (OOS) results, and customer complaints, and implement Corrective and Preventive Actions (CAPA) Product Development Project Manager
- Steer cross-functional teams to deliver their tasks and results per timeline
- Resolve problems for on-going projects.
- Manage supply chain operations for products including barcode, product instructions, and protocols Qualification Skills Education & Experience
- Degree: Bachelor's degree in food science, Pharmacy, Chemistry, Biochemistry, or a related scientific field
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Experience:
3+ years of experience in QA/RA roles Technical Knowledge
- Regulations: Understanding of food supplement regulations
- Certifications: Good working knowledge of GMP, HACCP, ISO 22000, or NSF certification standards
- Testing: Familiarity with analytical testing methods for vitamins, minerals, and botanicals (microbiology, heavy metals, stability testing) Soft Skills
- Attention to Detail: Meticulous approach to reviewing technical documents, formulations, and legal text
- Communication: Ability to translate complex regulatory jargon into clear guidance for marketing and sales teams
- Problem Solving: Strong analytical skills to handle product deviations and regulatory roadblocks efficiently
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