Pharmacien Responsable Exploitant / Senior Manager QA

Procter & Gamble; Dijon; Sur place; EUR 45 000 - 80 000; Plein temps

Résumé du poste

Join a forward-thinking company as a Pharmacien Responsable Exploitant / Senior Manager QA, where you will lead quality assurance initiatives that enhance consumer safety. This role offers a unique chance to impact millions by ensuring compliance with health regulations and driving quality improvements across products and suppliers. With a focus on continuous learning, you will collaborate with various departments and authorities, manage quality incidents, and support new product launches. Enjoy a dynamic work environment with generous vacation days, health benefits, and flexible work options, all while contributing to a mission that prioritizes public health and safety.

Prestations

27 paid vacation days

13 RTT days

Health insurance

Support for public transport costs

Eco-mobility support

Optional Tickets Restaurant card

Company restaurant

Flexible work from home

Onsite gym

Profit sharing and savings plan

Qualifications

• 5+ years of experience in QA within pharmaceutical or biotech industries.
• Deep knowledge of manufacturing medicinal products and medical devices.

Responsabilités

• Ensure compliance with quality standards and regulations.
• Lead quality improvement projects and manage critical quality incidents.

Connaissances

Quality Assurance

Risk-Based Quality Assurance

GMP

ISO 9001

ISO 13485

HACCP

GVP

GDP

Pharmaceutical Regulations

Bilingual (French and English)

Formation

Pharmacist License

5+ years in QA

Description du poste

Do you want to work on iconic brands? Initiate a rewarding career where the focus is on continuous learning & growth?

Our Pharmacien Responsable Exploitant / Senior Manager QA job offer is a unique opportunity to improve millions of consumers' lives.

As a Pharmacien Responsable Exploitant / Senior Manager QA, you will:

• Ensure the quality of PGHF products, services, and suppliers, CMs in compliance with regulations and customer quality requirements.
• Lead quality improvement projects at CMs.
• Develop and drive the implementation of local quality strategies.
• Manage CMs for local products according to P&G Healthcare standards.
• Contribute to the implementation of global quality strategies and standards.
• Provide support in all GxP-related training (GMP, GCP, GLP, etc.).
• Ensure the implementation and administration of the Local Quality Manual.
• Implement PHC standards, maintain documentation, and ensure procedures are up-to-date and compliant with global standards.
• Support product transfers and new product launches.
• Identify, record, investigate, approve, and close deviations.
• Manage recalls and market withdrawals processes.
• Maintain a system to secure complaints from GMP / GDP vendors, including vendor audits and quality agreements.
• Lead and manage critical quality incidents per P&G Healthcare Standards.
• Collaborate with drug and food safety departments and authorities as needed.
• Define, document, track, and close corrective and preventive actions to improve quality processes.
• Document and approve major and critical quality changes through formal change control processes.
• Report quality system status to local management regularly.
• Ensure the role of Qualified Person, including duties specified in article R5124-36 of CSP.
• Oversee the release of medicinal products and medical devices.
• Declare interactions with HCPs in accordance with French law.

Job Qualifications

You are the right fit if you have / are:

The Responsible Pharmacist of P&G Health France will be appointed based on decisions by the Sole Shareholder and registered with the Order of Pharmacists (Articles L.4221-2 and R.5124-20 of the Public Health Code).

You are proficient in French and English.

The minimum responsibilities of the Responsible Pharmacist are defined in Article R.5124-36 of the Public Health Code.

She / He is personally responsible for ensuring compliance with the provisions of the fifth part of the Public Health Code related to their activities, without prejudice to any joint liability of the company (Article L.5124-2).

She / He must ensure compliance with professional ethics and all regulations established in the interest of public health (Article R.4235-68).

She / He is responsible for defining roles and responsibilities of pharmacists and personnel under their authority, and ensuring proper training in good practices and procedures.

Minimum 5 years of QA or relevant experience in pharmaceutical and/or biotech industries, with at least 6 months in a pharmaceutical company (décret n° 2022-324 of 4th March 2022).

Demonstrated working knowledge of Quality Assurance principles, including Risk-Based Quality Assurance.

Deep knowledge of manufacturing medicinal products, medical devices, biocides, food supplements, cosmetics.

Broad understanding of drug development and regulatory environment.

• Good knowledge of GMPs, ISO 9001, ISO 13485, HACCP, GVP, GDP, and other quality systems.

Technical experience in Quality Assurance roles such as Quality Systems and Compliance & Auditing.

Experience in QA within pharmaceutical companies is required.

Advantages include:

27 paid vacation days, 13 RTT days (including 5 collective), and 3 bridge days.

Profit sharing and savings plan with company contribution.

Health insurance and mutual coverage.

Support for public transport costs or eco-mobility.

Optional Tickets Restaurant card.

Company restaurant, flexible work from home, onsite gym, and other employee benefits.

Interested? Learn more about P&G and our impact through the provided links.

Our hiring process involves application, online assessments, and interviews. We value diversity and promote inclusive opportunities.

Job Schedule: Full time

Job Number: R000112745

Segment: Experienced Professionals