Packaging GMP Specialist

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 discipline
• More than 5 years of hands-on experience in Finished Goods Manufacturing, ideally with a specialization in GMP-compliant packaging operations
• In-depth understanding of GMP principles, particularly those outlined by the FDA, to ensure adherence throughout packaging processes
• Fluency in both Danish and English, with strong communication skills in writing and speaking

Contract:

• 12 month contract
• Based in Copenhagen
• Start date ASAP
• 40 hours per week