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As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor or advanced degree in chemistry, biochemistry, microbiology, pharmacy or closely related discipline.
- Thorough knowledge of the Food and Drugs Act, Food and Drug Regulations, GMP Regulations.
- Thorough knowledge of Pharmaceutical Compendia and a deep understanding of pharmaceutical manufacturing methodology and analytical procedures.
- Preferably, three to five years’ experience in a pharmaceutical QA/QC environment.
- Works independently in a self-managed environment.
- Able to interpret data and information from a variety of sources drawing appropriate conclusions based on a thorough understanding of good scientific practice, good manufacturing practice requirements and company policies and procedures.
- Investigates and/or assists others in the investigation of issues with the potential to impact product quality and/or compliance to GMP requirements.
- Suggests and implements solutions balancing good science, product quality impact, GMP compliance, cost and business needs.
- Accepts responsibility for self and team.
- Ability to work under pressure and make rapid and accurate decisions.
- Challenges existing methods and processes in an effort to find areas for improvement.
- Drives the implementation of new methods and processes.
- Competent in using personal computer and MS office package software. Familiarity with LIMS desirable and SAP required.
- Strong interpersonal skills.
- Able to balance a variety of tasks with the appropriate priority.
- Well-developed written and verbal communication skills.
- Aptitude for critical thinking and problem solving.
- Provides assurance, through independent assessment, consulting and educating to Elanco Canada and its local and global business partners who conduct GxP activities on Elanco’s behalf, to ensure compliance with Canadian regulatory expectations and global quality standards.
- Complete product quality representative responsibilities as appropriate.
- Provides continuous quality improvement to regulated processes, practices and documentation at Elanco Canada and third parties.
Product Batch Release:
- Ensure the disposition/release of high-quality products, in accordance with approved internal and corporate standard operating procedures, specifications, Health Canada regulations and product specific regulatory commitments.
- Includes evaluation of transportation, storage, and distribution conditions.
- Participates during inspections from regulatory agencies, corporate and collaboration partners ensuring compliance to all required corporate and local regulatory agency policies, procedures, regulations, and guidance documents.
- Co-develops and executes yearly audit planning based on compliance risk criteria and may act as lead auditor for external and self-inspections based on level of experience, training and certification.
- Provides technical assistance and training to Canadian supplier sites on GMP and Elanco quality standard expectations.
- Coordination and assessment of product specific stability data in accordance with the approved stability schedule, stability protocol, specifications and development of standard operating procedures in accordance with Health Canada Regulations and corporate standards.
- Completion of scheduled activities as listed on the site quality plan.
- Maintain and/or establish quality agreements with contractors to ensure adherence to Elanco and regulatory authority requirements/cGMP.
- Provides advanced SAP technical support to affiliate business units as required.
- Provide technical support for SOPs and interpretation of global quality standards and regulation.
- Prepare and deliver GxP training based on level of experience and expertise.
- Proactively consults with global QA representatives, third party representatives and industry.
- Provides QA support to pharmacovigilance group and may act as local liaison for manufacturing site QA personnel for complaint sample returns and inspections.
- Provides technical support to internal and external clients.
- Acts as recall coordinator, as required.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status