Operational / Product Quality Assurance

In what environment will you work as an Operational / Product Quality Assurance Consultant (M/F)?

 

We are recruiting, on behalf of one of our clients in the pharmaceutical industry, an Operational / Product Quality Assurance Consultant (M/F) for a 6-month, renewable on-site assignment based in the Loiret department, France.

 

Mission context

Reporting to the Operational Quality Assurance department and directly to the QA Manager responsible for the deviation management process, you will serve as the primary Quality Assurance contact for the Production, Maintenance, Logistics, and Quality Control teams.

You will be responsible for investigating, managing, and resolving quality events affecting product compliance. The role includes key decision-making responsibilities regarding the assessment of deviation criticality and the approval of associated corrective actions.

 

Operational / Product Quality Assurance Consultant (M/F): What will be your roles and responsibilities?

 

Quality Event & Deviation Management

• Manage and assess internal quality events using the TrackWise quality management system, ensuring data completeness and compliance.
• Conduct thorough shop-floor investigations, gathering facts and collaborating directly with cross-functional teams.
• Assess product quality impact and determine the criticality of deviations.
• Define, approve, and monitor Corrective and Preventive Actions (CAPAs).
• Prepare and approve deviation summaries and investigation reports.
• Escalate significant quality events to management when they may impact product quality, financial performance, or company reputation.
• Ensure timely and compliant closure of deviation records.

 

Shop Floor Quality Support & Continuous Improvement

• Act as the day-to-day QA representative for manufacturing areas, providing on-the-floor support, coaching, and guidance to operational teams in preventing quality deviations.
• Contribute to employee training through lessons learned, knowledge sharing, defect libraries, and deployment of quality best practices.
• Draft, review, and update quality documentation, including Standard Operating Procedures (SOPs), quality procedures, and investigation guidelines.

 

Additional Quality Activities

• Support other quality systems as required, including investigations related to Out-of-Specification (OOS) results and customer complaints.

 

What profile and skills are required for this Operational / Product Quality Assurance Consultant (M/F) position?

 

Experience

• Proven experience in Operational Quality Assurance and/or Product Quality Assurance within the pharmaceutical industry.

• Demonstrated expertise in conducting shop-floor investigations and problem-solving in a GMP-regulated manufacturing environment.

 

Skills & Competencies

 

Technical Skills

• Strong proficiency with TrackWise.
• Solid knowledge of Good Manufacturing Practices (GMP).
• Excellent command of root cause analysis methodologies (e.g., 5 Whys, Ishikawa/Fishbone Diagram).
• Strong technical writing skills, with the ability to produce clear and robust quality investigation reports.

 

Behavioral Competencies

• Excellent interpersonal and communication skills.
• Strong shop-floor presence with an assertive and collaborative approach.
• Sound judgment and decision-making capabilities.
• High level of accuracy, organization, and responsiveness.

 

Education

• Master's degree (MSc), Engineering degree, PharmD, or equivalent qualification in Chemistry, Biology, Pharmacy, Quality Management, or a related scientific discipline.

 

Interested in this opportunity? Send us your application!

 

EP2C Energy is committed to diversity and inclusion. We encourage applications from individuals with disabilities.

 

As part of our Quality, Health, Safety and Environment (QHSE) policy, we place great importance on compliance with QHSE rules to ensure a safe working environment for our employees, with a strong commitment to environmental responsibility.

 

Our company is engaged in a continuous improvement approach through its Quality Management System (QMS) and Health, Safety and Environment Management System (HSE-MS).

 

By joining our teams, you will follow HSE procedures and best practices while contributing to the continuous improvement of our processes.