Quality Assurance Operations Specialist

Randstad Switzerland; Luzern; Híbrido; CHF 90 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Hybrid work (2 days remote per week)

Resumo da oferta

Randstad Switzerland seeks a Quality Assurance Operations Specialist to support GMP material release/review and related QOS activities. The role involves reviewing GMP records and ensuring compliance, with a regular day structure and coordination with the QA team.

The ideal candidate has a Bachelor’s degree or higher, experience in a regulated environment, and German C1 along with business-level English. The position offers hybrid work with two days remote per week in Switzerland.

Qualificações

• University degree (bachelor or higher) preferred.
• Experience in a regulated environment is an advantage.
• Previous experience in a similar role.
• German C1 is must have, English business proficient is highly expected.

Responsabilidades

• Participate in the release or rejection of GMP materials and components.
• Perform documentation, system or any GMP record review related to QOS activities.
• Conduct all work to high standards for quantity, integrity, quality and GMP compliance.

Conhecimentos

German C1

English proficiency (business)

GMP / GxP experience

Formação académica

Bachelor's degree or higher

Descrição da oferta de emprego

For one of our clients, an international pharmaceutical company, we are seeking a Quality Assurance Operations Specialist.

General Information:

• End Date: 31.10.2028
• Home office: Possible, 2 days per week
• Working hours: Standard

About the work:

The Global Development Quality OPS team is responsible to drive or support compliance-based programs and results which include support cross functional projects, solving simple problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, SOP management, and site procedures.

Task & Responsibilities:

• Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
• Perform documentation, system or any other GMP record review in relationship with the QOS activities
• Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance

“Day in the job”:

3 times per week the day starts at 8:30 with a team meeting to discuss ongoing activities. During the day, the person will work on records review

Requirements:

• University degree (bachelor or higher) is preferred
• Experience in a regulated environment is an advantage
• Previous experience in a similar role
• German C1 is must have, English business proficient is highly expected