QA Expert Analytics 9 months fix-term contract 80-100% (f/m/d)

Lonza; Basel; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza Basel Stücki is seeking a QA Expert Analytics DP to join our Drug Product Services (DPS) team on a fixed-term contract. You will provide QA support to QC analytical testing and ensure GMP compliance across laboratories.

You bring a university degree in pharmacy or life sciences and several years' GMP-regulated experience, with strong English communication and cross-functional collaboration skills.

Qualifikationen

• University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or related field.
• Several years of GMP-regulated pharmaceutical experience with QA support to QC labs and analytical testing.
• Strong knowledge of GMP, quality systems, and analytical lab operations; familiarity with LIMS, DMS, Trackwise or equivalents.
• Experience managing Deviations, OOS investigations, CAPAs, and Change Controls.
• Good communication and stakeholder management in a matrix environment.
• Excellent written and spoken English.

Aufgaben

• Provide QA support to QC functions (clinical and commercial) for GMP compliance-related activities within analytical testing laboratories, including physicochemical and bioassay testing.
• Ensure implementation and adherence to Corporate GMP Quality Manuals and applicable quality standards across Drug Product testing sites.
• Review and approve documentation related to: Analytical method validation, Specifications, Release testing, Stability studies.
• Perform review and approval activities in electronic systems such as LIMS, iLab, DMS, and other GMP-relevant platforms.
• Review and approve Change Controls, Deviations, OOS investigations, and CAPAs related to products, processes, and analytical activities.
• Author, review, and approve GMP documents, including SOPs, procedures, gap assessments, and compliance-related tools.
• Support analytical release activities and technical release of drug product batches.
• Participate in and support customer audits, and health authority inspections.
• Promote and enforce compliance with internal policies and external regulations, including GMP requirements, quality standards, and HSE regulations.
• Collaborate with cross-functional stakeholders to drive continuous improvement and maintain a strong quality culture.

Kenntnisse

GMP knowledge

Stakeholder management

English proficiency

Ausbildung

University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences

Tools

LIMS

DMS

Trackwise

Jobbeschreibung

The actual location of this job is in Basel Stücki, Switzerland.

For our successful Drug Product Services (DPS) focused branch located in Basel and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the fix-term contract QA Expert Analytics DP position.

What you will get:

An agile career and a dynamic work culture

An inclusive and ethical workplace

Compensation programs that recognize high performance

What you will do:

Provide QA support to QC functions (clinical and commercial) for GMP compliance-related activities within analytical testing laboratories, including physicochemical and bioassay testing.

Ensure implementation and adherence to Corporate GMP Quality Manuals and applicable quality standards across Drug Product testing sites.

Review and approve documentation related to:

Analytical method validation

Specifications

Release testing

Stability studies

Perform review and approval activities in electronic systems such as LIMS, iLab, DMS, and other GMP-relevant platforms.

Review and approve Change Controls, Deviations, OOS investigations, and CAPAs related to products, processes, and analytical activities.

Author, review, and approve GMP documents, including SOPs, procedures, gap assessments, and compliance-related tools.

Support analytical release activities and technical release of drug product batches.

Participate in and support customer audits, and health authority inspections.

Promote and enforce compliance with internal policies and external regulations, including GMP requirements, quality standards, and HSE regulations.

Collaborate with cross-functional stakeholders to drive continuous improvement and maintain a strong quality culture.

What we are looking for:

University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related scientific discipline

Several years of experience within a GMP-regulated pharmaceutical or biotechnology environment. Proven experience in Quality Assurance supporting Quality Control laboratories and analytical testing activities

Strong knowledge of GMP regulations, quality systems, and analytical laboratory operations. Familiarity with electronic quality and laboratory systems such as LIMS, DMS, Trackwise or equivalent

Experience managing and reviewing Deviations, OOS investigations, CAPAs, and Change Controls

Good communication and stakeholder management skills within a matrix environment

Excellent knowledge of written and spoken English

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.