Dijon
Job Description
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 life.
As a Pharmacien Responsable Exploitant/Senior Manager QA you will:
• Assures quality of PGHF products, services and suppliers, CMs in compliance with regulation and customer quality requirement,
• Leads Quality improvement projects at CMs.
• Develops and drives implementation of Local Quality Strategy;
• Assures the CMs for local products are managed according to P&G Healthcare standards;
• Contributes to implement the global quality strategy and standards of P&G Healthcare;
• Provides support in all GxP trainings related (GMP, GCP, GLP, etc.);
• Assures the Local Quality Manual implementation and administration; • Assures implementation of PHC standards, maintains a documentation system and ensures that all procedures are in line with the global procedures and are regularly updated;
• Provides support to product transfers and new product launches;
• Ensures deviations are identified, recorded, investigated, approved and closed; • Assures the recalls and market withdrawals processes are accordingly performed;
• Ensures a system to secure complaint from GMP/GDP critical vendors by: maintaining a vendor list, establishing Quality Technical Agreements, assuring vendors audits are regularly planned and performed and assure the products are manufactured in line with the Marketing Authorization;
• Leads and manages critical quality incidents according to P&G Healthcare Standards; • Interacts with drug and food safety department as well as authorities in the case of relevant issues;
• Ensures that corrective and preventive actions are timely defined, documented, tracked and closed in order to improve continuously the quality of the quality processes;
• Ensures that Quality major and critical changes are documented and approved according to a formal Change Control process and that the appropriate actions are taken before implementing the changes.
• Interacts with and reports the quality system status to local management on a regular basis
• Ensure the role of Qualified Person and will cover the duties as specified in the article R5124-36 of CSP (See Qualification)
• Assures the release for distribution of medicinal products and medical devices • Assures declaration of interactions with HCP (French specific law regarding HCP interactions)
Job Qualifications
You are the right fit, if you have/are:
- The Responsible Pharmacist of P&G Health France will be appointed to their position based on decisions made 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 in 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 the roles and responsibilities of pharmacists and personnel under their authority, and ensuring that they are trained in good practices and current procedures.
- Minimum 5 years QA experience or relevant experience in pharmaceutical and/or biotech industry with a least 6 months in Pharmaceutical company (décret n° 2022-324 of the 4thof March 2022)
- Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance – including those related to Risk Based Quality Assurance.
- In depth knowledge of manufacturing of medicinal products, medical devices, biocides, food supplements, cosmetic products
- Broad understanding of the drug development process and regulatory environment • Good knowledge of GMPs, ISO 9001, ISO 13485, HACCP, GVP, GDP and other relevant quality systems
- Demonstrated technical experience in Quality positions such as, Quality Assurance, Quality Systems and Compliance & Auditing;
- Experience in Quality Assurance of Pharmaceutical Companies (needed);
YOUR ADVANTAGES :
- 27 paid vacation days, 13 RTT (out of which 5 are collective ones) and 3 bridge days offered by the company
- Profit sharing and Company saving plan with company contribution
- Health mutual and insurance
- Company support for 50% on public transports costs in Paris area or eco mobility support (eg. bike)
- Tickets Restaurant card by Edenred (optional)
- Company restaurant
- Work from Home (2 to 3 days/week, depending on the job)
- Conciergerie services on site
- Gym room on site for free
- Work Council offers & subsidies
- Year-end hamper
- Coupons on our P&G products
ARE YOU EXCITED ABOUT THE ROLE? DEEP DIVE INTO P&G AND CHECK THE BELOW INSIGHTFUL LINKS:
- Our hiring process consists of three main steps: 1) application, 2) online assessments and 3) interviews. Click here to get all the tips to be fully prepared.
- P&G is driven to make life better, not just within the company, but across the globe. Click here to check out how we make a meaningful impact on the world.
- We are the world’s largest consumer goods company. Click here to discover about our iconic brands.
Encouraging diversity in all its forms, P&G is committed to creating an inclusive work environment and promotes equal opportunities.
Job Schedule
Full time
Job Number
R000112745
Job Segmentation
Experienced Professionals (Job Segmentation)
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