QA Specialist Manufacturing Goods
Company: International Biotech Organization
Location: Amsterdam Area
Starting date: Preferably December 2021
We’re currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer
Our client is at the forefront of immunotherapy and engineered T cell therapy. They are helping change the paradigm of cancer treatment and are revolutionizing individually tailored treatments. That means a fast-moving and constantly changing environment, where discoveries are made every day. We’re currently seeking to recruit highly motivated talents for different position to be part of the exciting journey in the development of innovative cancer immunotherapies and their translation into the treatment of patients with cancer.
• Performs a variety of QA activities to ensure compliance with applicable regulatory requirements and procedures.
• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues.
• Contribute to the Quality on the floor processes, including GEMBA walks and maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), and company procedures.
• Provides support to deviation lead/coordinators for deviations investigations and corrective and preventive action (CAPA) relating to manufactured products and contributes to the QA review and approval process of deviations and CAPA.
• Identifies and reports deviations from approved processes and procedures to senior colleagues
• Works on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.
• Perform other duties as assigned.
Knowledge and skills:
• Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
• Demonstrates basic knowledge of FDA / EMA standards and quality systems.
• Demonstrates good verbal, written, and interpersonal communication skills.
• Demonstrates working knowledge in Microsoft Office applications.
Education & Experience:
• 2+ years of experience in a GMP environment and a BSc degree.
• Or 3+ years of experience in a GMP environment and Associated degree. (2 years undergraduate)
• Prior experience in pharmaceutical industry or similar bio industry is beneficial.
If you are interested in the position, please apply for this role, or email me at email@example.com