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
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