- 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.
- 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
- 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
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GxP Consultant - Paris, France - Prodensa Group s.r.o.
Description
Job DescriptionPosition:
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:
Requirements
Desired Qualifications:
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.
Requirements
Desired Qualifications:
