Senior Associate-Quality Assurance

At Elanco (NYCE: ELAN) – all of it begins with animals!

As a worldwide chief in animal well being, we’re devoted to innovation and delivering services to stop and deal with illness in cattle and pets. We’re pushed by our imaginative and prescient of ‘Meals and Companionship Enriching Life’ and our method to sustainability – the Elanco Wholesome Function™ – to advance the well being of animals, folks, the planet and our enterprise.

At Elanco, we delight ourselves on fostering a various and inclusive work atmosphere. We consider that variety is the driving drive behind innovation, creativity, and total enterprise success. Right here, you’ll be a part of an organization that values and champions new methods of considering, work with dynamic people, and purchase new expertise and experiences that may propel your profession to new heights.

Making animals’ lives higher makes life higher – be a part of our crew in the present day!

Minimal Qualification (schooling, expertise and/or coaching, required certifications): 

• Bachelor or superior diploma in chemistry, biochemistry, microbiology, pharmacy or carefully associated self-discipline.
• Thorough data of the Meals and Medication Act, Meals and Drug Rules, GMP Rules.
• Thorough data of Pharmaceutical Compendia and a deep understanding of pharmaceutical manufacturing methodology and analytical procedures. 
• Ideally, three to 5 years’ expertise in a pharmaceutical QA/QC atmosphere. 

Expertise:

• Works independently in a self-managed atmosphere.
• In a position to interpret knowledge and knowledge from a wide range of sources drawing acceptable conclusions primarily based on an intensive understanding of excellent scientific apply, good manufacturing apply necessities and firm insurance policies and procedures. 
• Investigates and/or assists others within the investigation of points with the potential to influence product high quality and/or compliance to GMP necessities.
• Suggests and implements options balancing good science, product high quality influence, GMP compliance, value and enterprise wants.
• Accepts accountability for self and crew.
• Capacity to work below strain and make speedy and correct choices.
• Challenges present strategies and processes in an effort to search out areas for enchancment.
• Drives the implementation of latest strategies and processes.
• Competent in utilizing private laptop and MS workplace bundle software program. Familiarity with Veeva fascinating and SAP required.
• Robust interpersonal expertise.
• In a position to steadiness a wide range of duties with the suitable precedence.
• Nicely-developed written and verbal communication expertise. 
• Aptitude for vital considering and downside fixing. 

Place Description:

• Offers assurance, by way of unbiased evaluation, consulting and educating to Elanco Canada and its native and world enterprise companions who conduct GxP actions on Elanco’s behalf, to make sure compliance with Canadian regulatory expectations and world high quality requirements.
• Full product high quality consultant tasks as acceptable.
• Offers steady high quality enchancment to regulated processes, practices and documentation at Elanco Canada and third events.

Product Batch Launch:

• Make sure the disposition/launch of high-quality merchandise, in accordance with permitted inside and company commonplace working procedures, specs, Well being Canada laws and product particular regulatory commitments.
• Consists of analysis of transportation, storage, and distribution situations.

Auditing: 

• Participates throughout inspections from regulatory companies, company and collaboration companions making certain compliance to all required company and native regulatory company insurance policies, procedures, laws, and steerage paperwork. 
• Co-develops and executes yearly audit planning primarily based on compliance danger standards and will act as lead auditor for exterior and self-inspections primarily based on degree of expertise, coaching and certification. 
• Offers technical help and coaching to Canadian provider websites on GMP and Elanco high quality commonplace expectations.

Different Duties:

• Coordination and evaluation of product particular stability knowledge in accordance with the permitted stability schedule, stability protocol, specs and growth of ordinary working procedures in accordance with Well being Canada Rules and company requirements. 
• Completion of scheduled actions as listed on the positioning high quality plan. 
• Preserve and/or set up high quality agreements with contractors to make sure adherence to Elanco and regulatory authority necessities/cGMP.
• Offers superior SAP technical assist to affiliate enterprise items as required.
• Present technical assist for SOPs and interpretation of worldwide high quality requirements and regulation. 
• Put together and ship GxP coaching primarily based on degree of expertise and experience.
• Proactively consults with world QA representatives, third celebration representatives and trade.
• Offers QA assist to pharmacovigilance group and will act as native liaison for manufacturing website QA personnel for grievance pattern returns and inspections. 
• Offers technical assist to inside and exterior shoppers.
• Acts as recall coordinator, as required.

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Elanco is an EEO/Affirmative Motion Employer and doesn’t discriminate on the idea of age, race, coloration, faith, gender, sexual orientation, gender id, gender expression, nationwide origin, protected veteran standing, incapacity or another legally protected standing

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