Quality Assurance Specialist for Pharmaceutical Products
hace 2 meses
Kymos Group is a dynamic Contract Research Organization (CRO) with a strong presence in the life sciences industry. With headquarters in Spain and laboratories in Spain, Italy, and Germany, as well as a liaison office in South Korea, we offer comprehensive bioanalytical and CMC analytical services to our clients. Our laboratories are GMP and GLP certified and GCP compliant, having been successfully inspected by EMA, FDA, and ANVISA.
About UsWe are committed to providing high-quality services that add value to our partners. Our team is young and dynamic, comprising over 200 employees who are passionate about innovation and dedicated to promoting diversity, gender-equality, well-being, and initiative within our organization. We encourage career development and internal promotion, ensuring that our staff members grow professionally and personally.
Job DescriptionThe Quality Assurance Specialist will be responsible for the following tasks:
- Revising manufacturing batch records and packaging batch records, as well as other batch review documents related to pharmaceutical products.
- Evaluating deviations, OOS/OOT, complaints, CAPA, and Change Controls of pharmaceutical products, ensuring compliance with GMPs and marketing authorisation or clinical trial authorisation requirements.
- Certifying batches susceptible to release to the market or for clinical trials.
- Reviewing Quality/Technical Agreements between our company and manufacturers and marketing authorisation holders, particularly in relation to batch certification activities.
- Reviewing and approving documentation related to our company's activities, including CoA, Site Master File, SOPs, and product specifications.
- Collaborating on the revision of audit reports carried out by third-party auditors for pharmaceutical product manufacturers.
- Supporting audits conducted by our clients and regulatory authorities.
- Participating in the implementation and improvement of our quality system.
We are seeking a candidate with a degree in Life Sciences, preferably Pharmacy, and at least 2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry. Experience with Biologicals is highly valued. The ideal candidate should have knowledge of Pharmaceutical Analysis, Quality Control, Manufacturing, and Quality Assurance, as well as Good Manufacturing Practices.
BenefitsAs a member of our team, you can expect:
- A dynamic work environment with a growing team of highly qualified professionals.
- Professional development opportunities and a collaborative atmosphere.
- A culture of empowerment that encourages growth and innovation.
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