Quality Assurance Pharmaceutical EngineerVirbac 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.
- 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.
Expected results: Ensures the Virbac Quality Group strategically plans resources for continuous improvement in compliance.
Profile
Requirements (Diploma and experience)- Bachelor's degree in Biology, Chemistry, Engineering or related field.
- Total number of years' experience required to fulfil the role: 4-8 years
Skills- 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.
