Quality Assurance Manager 80-100% (m/f/d)

We are looking for a motivated and committed Quality Assurance Manager for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a 12 month assignment with option for extension.

As part of the on-site Quality Unit, the QA Facility & Engineering team ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team's responsibilities include the quality oversight of the qualification status of all production equipment, automation systems, laboratory equipment, the building infrastructure, and the utilities of all four production areas on-site (large-scale production of monoclonal antibodies; medium-scale single-use technology for production of monoclonal antibodies; production of antibody-drug conjugates; production of synthetic molecules active substances).

Tasks

• You have end-to-end quality oversight on the qualified state of all assets in your assigned area
• You provide fit for purpose quality support for all the activities related to qualification & CSV, calibration, maintenance & reliability engineering
• You review and approve GMP records that cover technical change management, deviation management, CAPAs, risk assessments, and SOPs
• You coordinate and facilitate complex investigations, root cause analyses, technical risk assessments, and continuous improvement projects
• With your operations partner you present topics during health authority inspections and internal audits

Must Haves

• University degree in science or engineering
• Min. 3 years demonstrated experience in Quality Assurance at a pharmaceutical manufacturing site
• Practical experience in commissioning & qualification projects in highly automated GMP production facilities
• Well established confidence in setting precise guidance for QA compliance in technical changes, deviations and CAPAs
• Your collaboration with partners is characterized by outstanding communication and team work
• You manage to drive quality awareness with operations partners at all levels by integrating regulatory requirements, analytical problem solving and scientific rationale
• Excellent German and English language skills, both written and spoken

Are you interested? Don't hesitate and send us your complete application documents online today.

We will also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!

Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.

Kontakt
Kristof Wildmann

Arbeitsort
Basel

Pensum
80 - 100%

Position
Mitarbeiter

Branche
Elektro + Mechanik