Qc Hplc - Aubonne, Schweiz - Merck KGaA Darmstadt Germany

Merck KGaA Darmstadt Germany

Geprüftes Unternehmen

Aubonne, Schweiz

vor 1 Woche

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics.

Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

QC Manager

Your role:

An exciting opportunity has arisen to

join the Quality Control

of Aubonne Bio-manufacturing Plant.

Enter a new era while entering new QC facilities, join the QC team as

Quality Control HPLC & Biochemistry

Manager and contribute to deliver a consistent supply of quality medicines to patients.

As QC HPLC & Biochemistry Manager, you lead 25+ collaborators dedicated to the testing of Drug Substance (DS), Biotechnology In Process Control and Drug Product (DP).

Ensure the respect of the analytical Lead Time according to the target defined (in close collaboration with supply chain and production departments)
Trend results and identify out of specification and out of trend results. Manage deviations and related investigations.
Review and approve the analytics part of the PCS/CPV (DS and DP) plan and report (Provide and ensure data integrity of all data generated by QC laboratories)
Ensure the completion of compliance activities as per inspection, audit, pharmacopeia, file compliance check in close collaboration with site regulatory and compliance department.
Develop, monitor and ensure the management of resources, budgets and performance of the laboratory
Manage the continuous improvement of the QC HPLC & Biochemistry laboratory and the associated documentation update
Reviews and approves documents, e.g. methods and specifications, change control documents, risk assessments, deviations and investigations
Manage the activities as process owner of analytical equipment and their computerized systems
Manage the trending of analytical methods and define the appropriate actions

As a "Go-to Manager", you ensure the above is performed in accordance with the cGMPs, regulatory requirements and company standards.

You also successfully present and/or defend all the above in Inspection or Audit.

You will report to the Head of Quality Control, you liaise with peer QA and QC managers and you allow the QC testing labs to run smoothly whilst managing experienced collaborators eager to develop (themselves, the team, the company) in a context of growth, simplification, and changes.

Your profile:

5+ years of experience in QC in GMP environment
Proven ability to learn & adapt quickly
Proven experience as supervisor/manager with leadership skills
Team player with advanced communication skills in French & English
Awareness of pharmaceutical and regulatory requirements
Previous successful experience in positions interacting with other departments/sites
Advanced knowledge in part of the QC HPLC & Biochemestry scope depicted above and ability to bring "a plus" to the team and peers

What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.

We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology.

We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress