One of our key clients is looking for a Packaging GMP Specialist to join their team on a 12 month contract. In this role, you will be instrumental in supporting manufacturing operations by leading investigations into root causes, participating in enhancing GMP practices. Using a methodical and data-informed approach, you'll collaborate with various departments to uncover ways to boost both regulatory compliance and operational performance. Key responsibilities: Delivering frontline GMP guidance to the production team. Promoting a culture of continuous improvement to uphold quality and compliance standards.
Drafting and evaluating quality documentation such as standard operating procedures (SOPs), deviation reports, customer complaints, and change control records. Assisting with internal audits and external regulatory inspections. Contributing to complex, high-stakes projects by advising stakeholders to ensure GMP and business objectives are met. Your Qualifications:
A university degree in Engineering, Pharmaceutical Sciences, or a closely related disciplineMore than 5 years of hands-on experience in Finished Goods Manufacturing, ideally with a specialization in GMP-compliant packaging operationsIn-depth understanding of GMP principles, particularly those outlined by the FDA, to ensure adherence throughout packaging processesFluency in both Danish and English, with strong communication skills in writing and speakingContract: 12 month contractBased in CopenhagenStart date ASAP40 hours per week
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