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Senior Representative R&D Quality Assurance

49919
Senior Representative R&D Quality Assurance
sydney
New South Wales
Asia/Pacific
Australia
Elanco is a global, innovation-driven animal health company that develops and markets products to improve animal health and production in more than 75 countries. Elanco’s research and development focuses on products in veterinary healthcare and food animal productivity

Other Information:

Expected Travel: up to 10%

The facility has no access to public transport so a driver’s license and car is required

49919BR

• Proficient in one or more GXP areas, and may be seeking skills in other GXP areas.

Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

• Perform any other duties or serve in such other capacity as may be determined by Company management.

 

Responsible for providing Quality support and ensuring Quality oversight to assigned R&D projects & teams with understanding of key business drivers, and seeking to gain knowledge in broader areas.

• Develop strong partnership with all relevant stakeholders in R&D to understand their business needs and to be able to proactively provide quality input and assist with risk assessments.

• Participate in the creation and/or revision of relevant Quality procedures. Will support the rollout of quality processes for the site.

• Assist with preparation activities for regulatory authority inspections to enable inspection readiness at the site.

• Provide quality and compliance training to R&D personnel. May contribute to training content.

• Develop Quality skills to provide support for customers and for implementation of legal regulatory quality requirements. Seek continuous technical quality improvements.

• Ensure an effective quality system is implemented and maintained at the site to meet requirements of GLP, GCP, PV and the Elanco Quality System

• Review local and global procedures (SOPs and EFPs) to ensure compliance with Elanco Quality Standards and Policies as well as relevant regulatory requirements

• Assist QA team members with maintenance of Quality (Q) Agreements in support of Elanco R&D team’s activities. Assist with the initiation, review, and renewal of Q Agreements with assigned Quality team members. May maintain some Q Agreements independently.

• Anticipate customer (internal and external) needs and handle non-standard requests.

• Responsible for planning and conducting GXP oversight activities: GRP, GCP or GLP study protocol, in-life and data/reports reviews/audits; site process self-inspections; and GRP, GMP, GLP or GCP qualification and oversight activities for work completed at third parties. Issue inspection/audit reports, and review and approve responses and corrective actions.

Minimum Qualification (education, experience and/or training, required certifications):

Education:

• Bachelor’s Degree (minimum) in Pharmacy, Science, Engineering, or related field, or equivalent relevant experience.

 

Experience:

• Vaccine/animal health development experience, with R&D-related Quality Assurance.

• Ability to operate in a business focused R&D Quality organization recognized as a partner to both the R&D organization and CRO business partners.

• Knowledge in one of the following: GCP (VICH GL9) or GLP compliance in one or more global regulatory requirements (USDA, CFIA, MHRA/VMD, EMA).

• Knowledge of PC tools including all MS Office applications and Internet

• May lead small to medium scale projects with minimum to moderate risks.

• Knowledge of business process and the ability to work within the general business hierarchy.

• Ability to negotiate favorable outcomes while maintaining positive working relationship.

• Aware of risk-assessment methodologies, and project organization.

• Able to interpret regulations and policies, and to communicate and respond to associated questions.

• Ability to define problems, collect and review data, establish facts and draw valid conclusions.

• Ability to communicate effectively verbally and in writing.

• Ability to hold critical conversations well

• Ability to influence without authority.

• Ability to effectively work with teams.

• Ability to set priorities and manage multiple tasks.