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Lead Quality Assurance Specialist
Il y a 3 mois
Position Overview
Are you ready to contribute to renowned brands? Embark on a fulfilling career that emphasizes ongoing development and advancement.
Our opportunity for a Senior Quality Assurance Manager is a distinctive chance to enhance the lives of countless consumers.
As a Senior Quality Assurance Manager , your responsibilities will include:
• Ensuring the quality of products, services, and suppliers in accordance with regulatory standards and customer quality expectations.
• Leading initiatives aimed at quality enhancement within contract manufacturers.
• Formulating and executing the Local Quality Strategy.
• Guaranteeing that local products are managed per P&G Healthcare protocols.
• Assisting in the implementation of the global quality strategy and standards of P&G Healthcare.
• Providing support for all GxP training related to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), etc.;
• Overseeing the implementation and management of the Local Quality Manual; ensuring that all procedures align with global standards and are regularly updated;
• Supporting product transfers and the launch of new products;
• Ensuring that deviations are identified, documented, investigated, approved, and resolved;
• Managing the processes for recalls and market withdrawals effectively;
• Establishing a system to secure complaints from critical vendors by maintaining a vendor list, creating Quality Technical Agreements, and ensuring regular vendor audits are conducted;
• Leading and managing significant quality incidents in accordance with P&G Healthcare Standards;
• Collaborating with drug and food safety departments as well as regulatory authorities on pertinent issues;
• Ensuring timely definition, documentation, tracking, and closure of corrective and preventive actions to continuously enhance quality processes;
• Documenting and approving significant quality changes following a formal Change Control process, ensuring appropriate actions are taken prior to implementation.
• Regularly interacting with and reporting the status of the quality system to local management.
• Fulfilling the role of Qualified Person and covering duties as specified in relevant regulations.
• Ensuring the release of medicinal products and medical devices for distribution.
• Ensuring compliance with laws regarding interactions with healthcare professionals.
Qualifications
You will be an ideal candidate if you possess:
Registration as the Responsible Pharmacist with the Order of Pharmacists, as determined by the Sole Shareholder. Proficiency in both French and English. A minimum of 5 years of experience in Quality Assurance or relevant experience in the pharmaceutical or biotech sectors, including at least 6 months in a pharmaceutical company. A comprehensive understanding of Quality Assurance principles, including Risk-Based Quality Assurance. In-depth knowledge of the manufacturing processes for medicinal products, medical devices, biocides, food supplements, and cosmetic products. A broad understanding of the drug development process and regulatory landscape. Familiarity with GMPs, ISO 9001, ISO 13485, HACCP, GVP, GDP, and other relevant quality systems. Demonstrated technical experience in Quality Assurance roles, including Quality Systems and Compliance & Auditing.Benefits
Generous vacation policy, including 27 paid vacation days and 13 RTT days. Profit-sharing and a company savings plan with contributions from the company. Health insurance and mutual support. Financial support for public transport costs or eco-friendly mobility options. Optional meal vouchers. On-site dining facilities. Flexible work-from-home options. On-site concierge services. Complimentary access to an on-site gym. Employee benefits and subsidies through the Work Council. Year-end gifts. Discounts on P&G products.Join Us
P&G is dedicated to fostering diversity in all its forms and is committed to creating an inclusive workplace that promotes equal opportunities.
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