Quality Assurance Operations

K-Recruiting Life Sciences; Luzern; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

K-Recruiting Life Sciences is seeking a Specialist GDQ QOS – GMP Quality Operations to support the Global Development Quality Operations team and ensure GMP compliance across development activities.

Responsibilities include reviewing GMP documentation, participating in batch release activities, and contributing to SOP management and cross-functional quality projects. A keen eye for detail and the ability to work independently are essential; fluent German (C1) is mandatory.

Qualifikationen

• Bachelor’s degree or higher in Life Sciences or related field.
• Experience in Quality Assurance/Quality Operations in regulated environments.
• Hands-on GMP documentation, record review, or quality systems.
• Fluent German (C1) mandatory.
• Strong attention to detail and ability to work independently with high accuracy.

Aufgaben

• Support the Global Development Quality Operations (GDQ OPS) team to ensure GMP compliance and quality standards.
• Perform GMP documentation, system, and quality record reviews in support of Quality Operations activities.
• Support the release or rejection of GMP materials and components through batch release activities and quality programs.
• Review quality records and documentation for accuracy, completeness, integrity, and GMP compliance.
• Support identification and resolution of quality-related issues and contribute to GMP quality initiatives.
• Contribute to quality system improvements, SOP management, compliance monitoring, and cross-functional quality projects.
• Work closely with stakeholders to ensure timely and compliant completion of quality activities.

Kenntnisse

Quality Assurance

Quality Operations

GMP

Documentation

cGMP

German language (C1)

Ausbildung

Bachelor’s degree or higher in Life Sciences/related

Jobbeschreibung

Specialist GDQ QOS – GMP Quality Operations (M/W/D)

Responsibilities:

• Support the Global Development Quality Operations (GDQ OPS) team in ensuring GMP compliance and quality standards.
• Perform GMP documentation, system, and quality record reviews in support of Quality Operations activities.
• Support the release or rejection of GMP materials and components through batch release activities and critical quality programs.
• Review quality records and documentation for accuracy, completeness, integrity, and compliance with GMP requirements.
• Support the identification and resolution of quality-related issues and contribute to ongoing GMP quality initiatives.
• Contribute to quality system improvements, SOP management, compliance monitoring, and cross-functional quality projects.
• Work closely with relevant stakeholders to ensure timely and compliant completion of quality activities.

Qualifications:

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related scientific discipline preferred.
• Previous experience in Quality Assurance, Quality Operations, GMP, or a similar regulated environment.
• Hands‑on experience with GMP documentation, record review, or quality systems.
• Understanding of current Good Manufacturing Practices (cGMP) and quality requirements.
• Strong attention to detail and ability to work independently with high standards of accuracy and compliance.
• Fluent German (C1) mandatory.
• Candidates with previous pharmaceutical or other highly regulated industry experience are strongly preferred.