QA Professional - Pharmacosmos

QA Professional
Elevate quality standards and processes by joining Pharmacosmos in a position that offers a far-reaching variety of QA assignments and responsibilities.

Job openings

Deadline

November 8, 2024

Department

QA

Apply via Venaris

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 distribu-tion of APIs and drug product. As QA Professional, you will conduct thorough reviews of manufac-turing 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 clo-sure, 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 of-fers 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.

How to apply
The recruitment process is carried out by Venaris Executive Search (www.venaris.dk). For more information regarding 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 by uploading your CV - it is not necessary to include a cover letter.

Apply via the blue link box in the top right