GxP Consultant

Position: GxP Consultant.

Contract: Freelance/Independent Contractor

Location: Paris, France

The company is a family-owned French pharmaceutical and dermatological laboratory, with a century-long history of growth and innovation. With a focus across various fields including Gastroenterology, Rheumatology, ENT, General Medicine, Dermo-cosmetics, and Medical Devices, it operates internationally with subsidiaries across the globe. Upholding values of Responsibility, Pragmatism, and Caring, the company aims to provide the best healthcare solutions and has a strong commitment to patient well-being. The company's expertise lies in manufacturing, environmental sustainability, and renowned brands. Over the years, it has expanded its portfolio through acquisitions and launches, emphasizing Consumer Healthcare.

Key Responsibilities:

• Formulating documentation for cleaning validations, analytical methods, and procedural processes.

• Conducting risk assessments across various GxP domains.

• Performing internal and external audits on both national and international scales.

• Contributing to the creation of Product Quality Reviews (PQR).

• Crafting and assessing technical papers such as Standard Operating Procedures (SOPs), protocols, and technical reports.

• Drafting documents and executing qualification and validation procedures for equipment and services.

• Collaborating with clients on project management activities.

• Overseeing the pharmaceutical quality system's document management system.

• Managing and drafting deviations and change controls, including thorough investigations.

• Supervising Corrective and Preventive Action (CAPA) plans and tracking their implementation.

• Providing Quality Assurance support for computerized system validation.

• Reviewing and assisting in the drafting of User Requirement Specifications (URS) from a Quality Assurance standpoint.

• Contributing to the supplier approval process.

• Ensuring suppliers and clients maintain GxP certification standards.

Requirements

Desired Qualifications:

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• Bachelor's degree in Pharmacy, Biology, Chemistry, Engineering, or related disciplines, with a keen interest in specializing in the GxP domain.

• A Master's degree in Pharmaceutical Industry or equivalent is advantageous.

• Prior experience in a Good Manufacturing Practice (GMP) environment with knowledge of best documentation practices.

• Proactive individuals with strong analytical and problem-solving capabilities.

• Excellent communication and teamwork abilities.

• Availability for on-site work at our facilities.

• Training in project management is preferred.

• Native-level of French language

• Proficiency in English with high-level comprehension and writing skills.

• Knowledge of additional languages is beneficial.

• Senior-level experience: >3 years

Benefits

• Global Reach: The opportunity to work on projects with international impact, spanning over 100 countries.

• Stability: Joining a reputable and stable organization with over a century of experience in the pharmaceutical and dermatological industries.

• Family-Owned Environment: Being part of a supportive and familial work environment, fostering a sense of community and belonging.

• Commitment to Healthcare: Contributing to meaningful work focused on providing effective, reliable, and accessible healthcare solutions.

• Independence and Long-Term Vision: Engaging in projects with a forward-thinking approach and a focus on long-term development plans.

• Manufacturing Expertise: Collaborating with a company known for its high-quality products and processes, with manufacturing expertise of over 100 years.

• International Development Opportunities: Opportunities to work across diverse markets and regions, gaining valuable international experience.

• Collaborative Work Culture: Joining a collaborative culture where teamwork is emphasized, working alongside passionate and committed individuals united in promoting everyday health and well-being.