CAM Bioceramics is a manufacturer of Calcium Phosphate ceramic materials used as components in Medical Devices and Excipients. It is an energetic environment operating under ISO13485 and GMP. The current QA team, composed of 4 members, ensures compliance and excellence of our internal processes. We are looking for a new member, possibly at an entry level, proactive and with a high level of attention to details. Key responsibilities
Perform detailed batch record reviews to ensure completeness, accuracy, and compliance with regulatory requirements (e.g., ISO 13485). Identify and elevate any discrepancies or deviations in production records. Collaborate with Production, Quality Control, and Regulatory Affairs to resolve documentation issues. Support QA documentation processes including filing, archiving, and audit preparation. Assist in the development and continuous improvement of QA processes and SOPs. Monitoring and maintaining QMS controlled documents (inform owners about periodic review). Recording and reporting quality data, provide input for management. Our ideal candidate profile
Strong attention to detail - spotting inconsistencies and documentation gaps is second nature to you. Comfortable working in a highly regulated environment with a structured and organized approach. Some experience in a GMP or ISO 13485-regulated setting is a plus, but not required. Analytical mindset with good written and verbal communication skills. A collaborative team player who can also work independently when needed. Bachelor’s degree in Life Sciences, Engineering, or a related field preferred, or equivalent work experience as an administrative officer. What do we offer?
An annual salary tailored to your experience 27 public holidays (216 hours) per year on a full-time contract 8% holiday allowance (paid in May) 4% Individual Choice Budget (e.g. extra leave, sports allowance, bicycle plan or payment) Comprehensive onboarding and training for entry as QA professional A challenging role in an international company, within a dynamic and diverse team A culture that values ownership and initiative Exposure to cutting-edge manufacturing processes in the medical device field A supportive and ambitious team that works together to achieve goals, sees challenges as opportunities An inspiring and informal workplace at the Leiden Bio Science Park The opportunity to contribute to the health and well-being of people worldwide Freedom to contribute your own ideas and initiatives, with opportunities to develop and implement them Fast-growing organization where you can make a difference Cake: we love to celebrate successes together!
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QA Documentation Reviewer (FT) in Leiden werkgever: 360Pharma
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