Quality Assurance Pharmaceutical Engineer

Experiencing together a unique human adventure

Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.  

Quality Assurance Pharmaceutical Engineer

Virbac Animal Health is seeking a Quality Assurance Pharmaceutical Engineer - External for our Quality Assurance team. This position will conduct all external functions for Quality Assurance, including assessing Contract Manufacturing Organizations (CMOs) compliance to cGMPs, review of Batch Records, Change Controls, applicable regulations and applicable company policies.  This role will also serve as Quality Assurance oversight for Virbac material suppliers, service providers, and contract laboratories as required.  Periodic domestic and international travel is expected; a valid passport is required.

Qualified candidates should have experience in the following:

• Pharmaceutical Manufacturing and/or Aseptic Manufacturing

• Quality Assurance Auditing and/or Engineering

• Batch Record review for drug and/or sterile products

• Experience with regulatory bodies (FDA, USDA, EMA)

Location Requirement:

• Strong preference for candidates in the St. Louis area

Compensation & Benefits:

• Competitive Pay and Bonus Opportunity

• 401k Match: 6%

• Paid Time Off (All Prorated):

  • 13 Company-paid Holidays

  • 15 Vacation Days

  • 5 Personal Days

  • 5 Floating Holidays

  • Growth Opportunities

Area of responsibility 1: [GMP Compliance at Affiliates/CMOs].

Main activities

• Ensure Suppliers meet industry and Virbac standards set forth by Regulatory agencies and Virbac.

• Ensure supplier qualification is performed per established Virbac policies and meets all regulatory requirements for all applicable government agencies.

• Assist in development and maintenance of audit schedules.

• Proactively identify and manage changes in controlled processes and procedures following changes in industry practices or regulations, ensuring high quality standards with applicable laws, regulations, guidelines, and Virbac policies.

Expected results: Ensures the supplier qualification program meets Virbac and Regulatory requirements.

Area of responsibility 2: [Quality Assurance]

Main activities

• Review and approve deviations, batch documentation, Out-of-Specification, Out-of-Trend and change requests from suppliers.

• Trend performance metrics for suppliers and report regularly to help identify potential shifts in supplier performance before supply is impacted.

• Track post-audit improvement actions and report regularly on implementation progress.

• Perform effectiveness audit of the implemented improvement actions.

• Identify and present evidence of quality and compliance risks to QA Management as they appear.

• Assist with management of supplier assessments and the Virbac Approved Supplier List.

Expected results: Ensures a low level of quality risk and a high level of confidence in quality by customers.

Area of responsibility 3: [Quality Planning].

Main activities

• Perform, track and manage actions required to maintain a compliant supplier qualification program.

• Identify and present evidence of quality and compliance risks to QA Management.

• Design and develop quality improvement strategies and plans.
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