| Contract Type: Permanent Full-time; Independent Contributor; Quality Assurance role Reports To: Director, Regional Quality- North America Location: Princeton, NJ USA | Some telecommuting is allowed Summary This is an exciting opportunity for a dynamic professional to join our Global Quality team at a time of expansion within the company. ECO Animal Health is a global organization, headquartered in the UK, specializing in veterinary pharmaceuticals and biologics, predominantly for production animals. We are dedicated to the research, development and marketing of both new products and innovative, differentiated generics. The company is well established with over 20 years of experience operating in the pharmaceutical animal health sector. The Role is responsible to adhere to and support Quality Management System and company-wide Quality initiatives to assure product integrity and compliance with regulatory requirements (FDA, EMA, Health Canada, etc) and internal/global standards and procedures Serve as ECO technical and quality / GMP contact to contract manufacturers, development, and analytical sites in North America and specific RoW locations. S/He will support ECO Animal Health technical and quality GMP and R&D activities, liaise with contract manufacturers and laboratories, collaborate with internal ECO partners across multiple disciplines as necessary to meet company goals and timelines, and has the flexibility to undertake other duties and/or special projects as requested. Specific responsibilities include, but is not limited to: - Act where required as the ECO “Authorized Person” for the final dispositioning of finished goods
- Ensure that product release by contract facilities is performed according to QA and QC procedures and that any deviations or failures are appropriately investigated and resolved
- Provide technical support, coordinate technical transfers, review manufacturing and testing specifications, methods and validations for accuracy and compliance with product registrations
- Coordinate and monitor stability program; review and trend data
- Facilitate or participate in investigations of deviations, OOT and OOS, product quality complaints investigations and recall operations activities when necessary
- Initiate or evaluate ECO internal change proposals; evaluate and approve contract facilities’ change proposals
- Conduct or arrange for Annual Reports and Annual Product Reviews
- Ensure that contract facilities Quality Technical Agreements are established and maintained
- Conduct analyses of key technical documents and participate in improvement initiatives with respect to QMS
- Author and/or review standards and procedures (SOPs) and ensure their completeness and timely training
- Participate as the ECO sponsor representative in GMP-related regulatory inspections at contract facilities
- Conduct or arrange Quality audits of contract facilities and ensure that any out-sourced functions are commissioned and completed in accordance with company requirements.
- Prepare and/or review protocols and reports for studies required for CMC-related purposes
- Maintain current awareness of the appropriate GMP regulations and regulatory guidelines for a CMC
- Assist with license and registration renewal applications and maintenance thereof
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