Quality Assurance Pharmacist

Excelya Group; Boulogne-Billancourt; On-site; EUR 60,000 - 85,000; Full time

Job summary

Excelya in France is seeking a Quality Assurance Pharmacist to strengthen the Quality team and ensure regulatory compliance across the drug development and manufacturing lifecycle. You will oversee QMS documentation, product quality activities, and cross-functional collaboration with Manufacturing, Regulatory Affairs, and Pharmacovigilance.

The role covers deviations, CAPAs, change controls, batch release review, audits, and supplier interactions, plus training programs.

Qualifications

• Strong knowledge of GMP, GDP, GVP and Pharmacovigilance requirements.
• Experience managing Deviations, CAPAs, Change Controls and RCA.
• Experience with Quality Management Systems and tools such as TrackWise, EDMS, SAP.

Responsibilities

• Manage quality documentation including SOPs, procedures, and quality records.
• Coordinate document lifecycle activities: creation, review, approval, archiving, and periodic reviews.
• Participate in internal audits, supplier audits, and health authority inspections.
• Manage quality events including deviations, CAPAs, change controls, and continuous improvement initiatives.
• Review Product Quality Reviews (PQRs) and monitor quality trends.
• Review and approve batch release documentation and distribution-related activities.

Skills

GMP

GDP

GVP

Pharmacovigilance

Education

PharmD (Doctor of Pharmacy)

PRI registration (asset)

Tools

TrackWise

EDMS

SAP

Other QA Systems

Job description

At Excelya, we combine passion, scientific excellence, and collaboration to support our clients throughout the entire drug development lifecycle. We encourage our employees to be bold, take initiative, and unlock their full potential in an international, fast-growing environment.

We are currently looking for a Quality Assurance Pharmacist to strengthen our Quality team and support pharmaceutical quality systems, product quality activities, and regulatory compliance initiatives.

Key responsibilities :

Quality Management System (QMS)

• Manage and maintain quality documentation including SOPs, procedures, and quality records.
• Coordinate document lifecycle activities, including creation, review, approval, archiving, and periodic reviews.
• Support and deliver GxP and quality-related training programs.
• Participate in internal audits, supplier audits, and health authority inspections.
• Manage quality events including deviations, CAPAs, change controls, and continuous improvement initiatives.
• Ensure compliance with applicable pharmaceutical regulations and quality standards.

Product Quality Activities

• Manage product quality complaints and associated investigations.
• Support quality defect reporting and interactions with health authorities when required.
• Conduct risk assessments and quality impact evaluations.
• Participate in product recall and shortage management activities.
• Review Product Quality Reviews (PQRs) and monitor quality trends.
• Review and approve batch release documentation and distribution-related quality activities.

Quality Oversight & Continuous Improvement

• Monitor quality KPIs and performance indicators.
• Contribute to Management Reviews and Annual Quality Reviews.
• Support cross-functional initiatives such as product launches, technology transfers, and portfolio optimization projects.
• Drive quality culture and promote continuous improvement across the organization.
• Collaborate closely with Manufacturing, Supply Chain, Regulatory Affairs, Pharmacovigilance, and Quality stakeholders.

Education

• Doctor of Pharmacy (PharmD) mandatory.
• Strong experience in Quality Assurance within the pharmaceutical industry.
• Experience in pharmaceutical manufacturing or production environments is highly desirable.
• Registration as a Responsible Pharmacist (PRI) is considered an asset.

Technical Skills

• Strong knowledge of: GMP (Good Manufacturing Practices) GDP (Good Distribution Practices), GVP and Pharmacovigilance requirements
• Proven experience managing: Deviations, CAPAs, Change Controls, Root Cause Analysis (RCA), Risk Management activities
• Experience with Quality Management Systems and tools such as: TrackWise, EDMS, SAP, Other electronic Quality Systems

Language

• Fluent English, both written and spoken.

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.

Here's what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.