We are looking for a new colleague for the Compliance team to provide support to Finished Goods Manufacturing in all compliance and GMP related matters.
The Compliance team consist of 14 dedicated colleagues, with a broad variety of educational backgrounds. We support Finished Goods Manufacturing with batch preparation & review, handling of deviations and CAPA’s, document updates, Changes, Audits and optimization & tech transfer projects. We have a close collaboration with the production teams and QA, and we have many cross functional assignments. This makes it a very exciting team to be part of, if you thrive in an environment where stakeholder collaboration is key. You will be part of a team that is very competent and works with a high independence.
Your daily tasks as Compliance Associate will include
- Perform assessment of Finished Goods changes.
- Initiate deviations
- Establish and implement corrective and preventive actions to prevent re-occurrence and improve compliance.
- Ensure compliance of GMP documents and improvement of the compliance level
- Support and drive optimization projects to ensure continuously improvement of Finished Goods Manufacturing Processes
- Close cooperation with the Quality Assurance Department to ensure alignment on interpretation of GMP issues.
Bachelor or Master Degree within Pharmaceutical Sciences, Process Engineering or similar area
You have a minimum 3 years of GMP experience from the Pharmaceutical or Biotech industry. You can work independently on compliance related issues, deviations and optimization projects. You have knowledge and experience with interface between QA and Manufacturing. You understand and are able to execute against regulatory requirements.
You have a good level of technical writing skills and excellent communication skills in English and Danish (spoken and written).
As a person you are able to prioritize tasks to meet defined timelines. You work analytical and structured with a quality mind set. You enjoy working independently in a dynamic environment.
Please upload your CV and cover letter latest by 29th of November. For more questions please contact Talent Acquisition Lead Eva Op De Beeck, at +45 72210860.