QA Manager
Elanco
Auckland, NZ
3d ago

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.

The purpose of the role is to :

  • Review the production batch records, to ensure that it meets Elanco and ACVM standards and is fit for release to the market.
  • Prepare the Product Quality Review (PQR) for all the products manufactured at Elanco New Zealand.
  • Recommended operational and process improvements to promote efficiency whilst reducing overall costs.
  • Assign training to staff at Elanco New Zealand through Success Factors.
  • Mastering of documents for use. Job Responsibilities : 1. Product Release :
  • Ensure the production batch records are reviewed to meet Elanco and ACVM standards.
  • Ensure all QA related review is completed, and quality product is available for release in a timely manner.
  • Ensure any gaps identified in the batch records are escalated to the Production Leaders for correction in a collaborative and timely manner to enable timely release of product.
  • Facilitate the timely release of quality product by actively communicating with the key stakeholders to provide required documentation necessary for product release.
  • Identify and recommend improvements to the product release process to promote efficiency in the organization.
  • Support with the investigation and closure of deviations impacting on product release by working collaboratively with the investigator and key stakeholders to enable the timely release of the batch.
  • Ensure the QA okay to pack is completed on all products supplied to Elanco New Zealand for secondary packing to ensure any deviations with regards to product packaging / documentation are detected earlier.
  • 2. Product Quality Reviews :

  • Perform the Product Quality Review Program by completing the assigned Product Quality Reviews for products manufactured at Elanco New Zealand within the stipulated timeline. 3. Operational Excellence :
  • Identify opportunities of improvement by challenging the status quo (process, operations, and documentation).
  • Support Operation Excellence projects to promote efficiency whilst reducing overall cost. 4. Training :
  • Manage the Good Manufacturing Practice (GMP) training program to ensure all employees within Elanco New Zealand are trained in the ACVM GMP code required for the manufacture, testing, release, and supply of Veterinary Medicines.
  • Organize and administer the GMP training program by scheduling monthly training sessions.
  • Conduct the GMP training and engage with the employees to inculcate the importance of following the ACVM GMP code for the manufacture, testing, release, and supply of Veterinary Medicines.
  • Ensure all completed GMP training is updated in a training matrix and is available for review during an audit.
  • GMP Induction training for all new employees.
  • Load and assign Curricula to staff in Elanco New Zealand through Success Factors. 5. Health and Safety :
  • Ensure all hazards are identified and where responsible actioned appropriately and in timely manner through the process of elimination, minimization and isolation.
  • Ensure all accidents are reported as per the company Health Safety Environment requirements 6. Additional Duties :
  • Support the Product Supply operations team by participating in the daily production meeting to provide effective solutions for problems that prevent supply of quality products.
  • Support the goal to build quality in the process by increased QA presence in the production floor thereby better understanding of the production process and ability to provide solutions to improve product quality.
  • Ensure all documents associated with products are archived as per Elanco and ACVM requirements and can be easily accessible when required in an audit.
  • Manage the Pest Control Program in compliance with Elanco and ACVM guidelines. Minimum Requirements :
  • Bachelor’s degree in Science (e.g. pharmacist, chemist, physician, biologist) or comparable qualification.
  • Minimum 1-2 years’ experience in an established QA function
  • Detailed knowledge of GMP / GDP, QA / QC and / or ISO standards
  • Production experience, auditing experience, change management, deviation management and knowledge of the products 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
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