Quality Assurance Pharmaceutical Engineer

Virbac•Bridgeton, MO

24d

About The Position

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

Requirements

Bachelor’s degree in Biology, Chemistry, Engineering or related field.
Current knowledge of analytical and validation principles, local and international regulations, and regulatory policies.
Demonstrated skill in communicating with other departments, customers, and employees at all levels of the organization.
Demonstrated ability to make risk-based assessments requiring a high degree of understanding of the overall site objectives.
Demonstrated ability to work autonomously and make courageous and sound decisions.

Nice To Haves

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)

Responsibilities

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.
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.
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.
Support CMO/CPO changes, review batch records, and validation review among other duties such as generating supplier metrics, presenting in quality system management review.
Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/Risk Management, Clinical Operations and Regulatory to ensure appropriate cross-functional SOPs, policies or work instructions are in place and followed.
Provide regular updates to senior management, and participate in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships.