QA Professional

Holbæk, Denmark

Pharmacosmos

QA Professional

About the job QA Professional
Elevate quality standards and processes by joining Pharmacosmos in a position that offers a far-reaching variety of QA assignments and responsibilities.
Lead comprehensive QA processes
Reporting to the Internal QA Director, you will become part of a department (6 FTEs), responsible for ensuring GMP compliance and oversight regarding development, manufacturing, and distribution of APIs and drug product. As QA Professional, you will conduct thorough reviews of manufacturing batch records and associated documentation to ensure compliance with internal SOPs, GMP guidelines, and regulatory standards, primarily regarding drug product from CMOs. Moreover, you will investigate product complaints, identify root causes, and collaborate with cross-functional teams to implement CAPAs. Likewise, you will review deviations from SOPs and ensure timely closure, just as you will manage change requests related to processes, equipment, materials, and methods impacting product quality or regulatory compliance. Assisting in the planning, execution, and documentation of validation activities will also be on your agenda. Furthermore, this role offers a broad interface with different stakeholders as you will collaborate closely with Regulatory Affairs, Supply Chain, Manufacturing, R&D, QC, etc. to ensure quality processes and alignment with regulatory objectives. Finally, in addition to the classic QA assignments, this role also offers great opportunities to work with projects that are of particular interest to you.

Driven and curious QA profile with GMP experience
We expect you to hold a relevant scientific background such as pharmacist, engineer, chemist, or similar as well as experience from a QA position within the pharmaceutical industry, in which you have acquired solid knowledge from a quality assurance set-up. Likewise, you are used to QMS and communicating GxP requirements to stakeholders at all levels in an organization. Lastly, it is crucial that you are fluent in Danish and English both written and spoken.

Personally, you are structured, analytical, independent, and pragmatic with an eye for details. Collaborating with different people at all levels in an organization comes naturally to you, as you are a team player with a positive mindset and excellent interpersonal skills. Moreover, you are a strong ambassador of a quality mindset but also have a proactive and solution-oriented approach. You enjoy a dynamic pace with a broad range of tasks requiring you to balance risk and value to ensure quality and safety.

Unlock innovation and accelerate growth with Pharmacosmos
This is your chance to embark on an exciting journey with Pharmacosmos, as they continue to seize strategic opportunities, driven by a strong ambition to innovate new medicines to address unmet medical needs and help patients globally. The recruitment process is carried out byVenarisExecutive Search (www.venaris.dk).For more informationregarding the position,please reach out to Head of Research, Sofie Rudbech Mathisen, on+45 2512 1162. All requests will be handled confidentially.If this position is for you,do not hesitate to apply byuploadingyour CV-it isnot necessaryto include a cover letter.

Pharmacosmos
Founded in 1965, Pharmacosmos is a global healthcare pioneer in carbohydrate chemistry and a leader in the development of innovative treatments for blood diseases, including iron deficiency anemia and cryopreservation technology. On September 18th, 2024, Pharmacosmos announced the successful completion of their acquisition of G1 Therapeutics, a commercial-stage oncology company. The acquisition aligns perfectly with Pharmacosmos' strategy by leveraging their extensive expertise in blood diseases, positioning the company for its next phase of growth and strengthening its global commercial portfolio. Headquartered in Holbæk, Denmark, Pharmacosmos employs 650 dedicated employees, with products marketed in over 40 countries worldwide. Please also visit www.pharmacosmos.com