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 The incumbent is responsible to adhere to and support Quality Management Systems and cGMP compliance programs to assure product integrity and conformance with world-wide regulatory requirements and guidelines (FDA, Health Canada, EMA, etc.) as well as ECO Animal Health policies and standards. 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
Experience and Skills
At least 5 years direct experience in manufacturing-related QA activities.
Experience in QC, R&D laboratory and/or a manufacturing facility.
Detailed knowledge of international GMP requirements (FDA, EU, PIC/s for example) aligned with an understanding of global Regulatory process
Skillset: strong organization and communication skills, both spoken and written; ability to work well both independently and within a multi-disciplinary team; strong attention to detail
Telecommuting is allowed.
About ECO Animal Health
ECO Animal Health specializes in the development and marketing of high quality medicines for the control of disease in livestock and companion animals. We are dedicated to the research, development and marketing of both new products and innovative, differentiated generics. Our commitment to our customers is to provide them with products of a consistently high quality at an affordable and attractive price.