10 days old

Site GxP Coordinator/Archivist

Kemps Creek, NSW 2178
51681
Site GxP Coordinator/Archivist
Kemps Creek
New South Wales
Asia/Pacific
Australia

Elanco is a global animal health company that develops products and knowledge services to prevent and

treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously

innovate to improve the health of animals and benefit our customers, while fostering an inclusive,

cause-driven culture for more than 5,800 employees. At Elanco, were driven by our vision of food and

companionship enriching life all to advance the health of animals, people and the planet.

Ensure site is operating to applicable regulations and guidelines (e.g. OECD GLP, VICH GCP, and FDA GLP).

Ensure all practices and procedures on site are current, transparent and meet all GxP standards

Manage SOP systems and processes.

Record and review current practices and ensure future regulations are proactively adhered to through site systems.

Support and collaborate with global and local quality, responsible for the management of CAPA items raised from compliance audits

Responsible for all practices that are GxP-related from an operational stand point. These include job descriptions, organizational charts and operational metrics, as required.

Responsible for site archiving including wet specimens, test item/IVP, hard copy raw data, and electronic raw data. Ensure procedure for archiving reflects current regulatory requirements.

Responsible for the site master schedule and maintain adherence to OECD GLP requirements.

Active member of the Yarrandoo computerized system validation team

Member of the site quality committee

Track Wise specialized user to manage deviations, CAPAs and change requests

Track completion of site quality requirements

Maintain site governance to global quality standards

51681BR

Fluency in English is essential.

Ability to work additional hours as required

Min qualification in a scientific field

Proven track record in working to GxP standards including GCP and GLP

Strong knowledge of OECD GLP, VICH GCP and FDA GLPs

This position is aimed at providing support to Global Operations and Yarrandoo management for the oversight of the implementation and maintenance of GLP and GCP operations at Yarrandoo R&D center and to ensure harmonization of SOPs and systems to applicable GxP guidelines.

The GxP Coordinator/Archivist will liaise with the local site management team and all functional areas and is expected to be proactive, dynamic, change tolerant and have a strong understanding of GLP and GCP. The position will entail dealing with tight schedules, managing health authority requirements, local SOPs, change control systems and all forms of archiving to GLP standards.

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Categories

Industry

  • Science
Posted: 2019-09-05 Expires: 2019-10-05

As one of the oldest continuously operating companies in the United States, we are proud of all the innovative work we’ve accomplished for the last 140 years to improve global health.

We are looking forward to an even more successful future in which continued innovation and contributions from top talent in all areas of our organization will be critical.

Are you looking for a way to make life better for people around the world? We have opportunities in many areas of our organization. Please use the search feature to see the wide scope of our positions.

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Site GxP Coordinator/Archivist

Lilly
Kemps Creek, NSW 2178

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