Quality Control Scientist
Vor 2 Tagen
**About Us**
Consultys Group is a 100% specialist LifeScience consulting firm. With more than 550 experts working in France, Belgium, Germany and Switzerland on major engineering, R&D and compliance projects for the world's leading pharmaceutical, medical device and biotech companies.
Consultys links operational compliance, quality, processes, R&D, regulatory, own solutions and technology in ways that master complex business challenges to help its LifeScience clients exploit their existing strengths and develop new capabilities by combining its experience and innovative thinking across in the regulated environment.
**Role & Responsibilities**
- Comply with GMP requirements, policies and applicable QC procedures
- Identify and facilitate/lead problem-solving and improvement projects
- Responsible for writing validation or verification protocols and reports for analytical methods
- Responsible for writing qualification plans and reports for critical reagents and reference standards
- Oversee validation and qualification activities executed by analysts, provide training and support
- Support of analytical method transfers as transferring or receiving unit between R&D and Analytical Laboratories as well as within Operations
- Write assignment plans and reports for method controls, establish and perform evaluation of control charts
- Support and preparation of audits, audit responses and regulatory submissions
- Participate in multi-site projects as local project lead, working in collaboration with other QC scientists and Analytical Development groups
**Requirements**:
- University or engineering degree in Analytical Chemistry, Biotechnology, Biochemistry or related field
- At least 2 years of experience in GMP pharma business activities
- More than 1 year of experience in GMP laboratory activities
- Proven experience and knowledge in analytical method validation and verification
- Strong knowledge of regulatory requirements concerning analytical test methods and licenses
- Analytical and structured working style; strong attention to detail
- Ability to effectively work as part of a multidisciplinary, international team
- Hands-on personality, with flexibility and dedication to maximize our client's value
- Fluency in English is required, German, French or Italian would be a plus
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