Quality Assurance Specialist
2 settimane fa
About the Role:
We are seeking a seasoned Quality Assurance Associate to join our team at Amaris Consulting. As a key member of our pharmaceutical operations team, you will be responsible for overseeing the implementation of Quality Assurance (QA) programs and controls in collaboration with external clinical, manufacturing, and distribution sites.
Key Responsibilities:
Manage QA & Compliance for pharmaceutical third-party manufacturing operations and suppliers. Ensure compliance of batch documentation with cGMPs/GTPs, company standards, and product specifications. Authorize further processing of starting materials released by third parties. Manage deviation, chain of custody, and cold chain management. Ensure compliance with good tissue practices and national standards. Oversee management and storage of NC and COMET systems. Advise team members and stakeholders to meet established schedules. Resolve technical or quality operational issues. Monitor supplier quality activities for compliance.
Requirements:
Bachelor's degree in Life Sciences, Pharmacy, or related field. Proven experience in Quality Assurance within the pharmaceutical or biotechnology industry. Strong knowledge of cGMPs, GTPs, and regulatory standards. Excellent knowledge of the English language (C1 Level required). Excellent analytical, problem-solving, and communication skills. Ability to work collaboratively in a fast-paced environment.
What We Offer:
Work by objectives with quarterly monitoring. Educational and technical growth path. Inclusive work climate. Lunch vouchers of €8 per working day. Free access to Mantu Academy platform with more than 500 courses. Psychological counselling.
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