Quality Assurance Pharmacist

Excelya; Boulogne-Billancourt; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Excelya is seeking a Quality Assurance Pharmacist to strengthen our Quality team in France and support pharmaceutical quality systems, product quality activities, and regulatory compliance initiatives.

You will manage the QMS, coordinate documentation, participate in audits and inspections, and drive continuous improvement across manufacturing and quality functions. Fluent English is required; PharmD and QA experience in pharma are essential.

Formación

• PharmD mandatory and strong QA experience in pharmaceutical industry.
• Experience in pharmaceutical manufacturing or production environments is desirable.
• PRI registration is an asset.

Responsabilidades

• Maintain the Quality Management System (QMS) including SOPs and records.
• Coordinate document lifecycle activities: creation, review, approval, archiving, periodic reviews.
• Deliver GxP and quality training programs.
• Participate in internal audits, supplier audits, and health authority inspections.
• Manage deviations, CAPAs, change controls, RCA, and risk management activities.
• Review and approve batch release documentation and distribution-related quality activities.
• Collaborate with Manufacturing, Supply Chain, Regulatory Affairs, Pharmacovigilance, and Quality stakeholders.
• Monitor quality KPIs and contribute to management reviews.

Conocimientos

GxP Quality

Quality Assurance

Regulatory compliance

Audits

Risk management

CAPA management

Deviation handling

Cross-functional collaboration

Process improvement

English fluent

Educación

Doctor of Pharmacy (PharmD)

PRI registration (asset)

Herramientas

TrackWise

EDMS

SAP

Descripción del empleo

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.