Senior QA Specialist – Pharmaceutical Manufacturing

Swisslinx AG; Zürich; On-site; CHF 110,000 - 150,000; Part time

Job summary

Swisslinx AG in Zürich seeks a Senior QA Specialist to support GMP-compliant quality operations during commissioning, qualification and technology transfer in a major pharmaceutical project in Visp, Switzerland.

The role focuses on QA activities, GMP compliance, reviewing GMP docs, and contributing to regulatory readiness; you will collaborate with Quality Control, Engineering and Manufacturing to ensure successful execution and compliance.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, or a related field.
• Significant professional experience in pharmaceutical Quality Assurance or a closely related function.
• Proven experience in Quality Assurance, Manufacturing, or Engineering within a cGMP-regulated environment.
• Solid understanding of GMP regulations, quality systems, and pharmaceutical manufacturing processes.
• Experience reviewing GMP documentation and ensuring compliance with SOPs and quality standards.
• Strong knowledge of computerized systems used in pharmaceutical environments, such as SAP, TW, or similar platforms.
• Proficiency in quality risk management methodologies and tools, including FMEA.
• Ability to make independent, quality-focused decisions in a dynamic manufacturing environment.
• Strong organizational, communication, and cross-functional collaboration skills.
• Fluent English, both written and spoken.

Responsibilities

• Manage QA Operations activities during commissioning, qualification, and technology transfer phases.
• Assess and manage quality-related activities impacting GMP manufacturing operations.
• Coordinate with cross-functional teams (Quality Control, Engineering, Manufacturing) for timely execution of activities.
• Support daily QA operations per SOPs, policies, and GMP requirements.
• Review GMP documentation and manufacturing records to ensure cGMP compliance.
• Make timely, risk-based quality decisions regarding manufacturing events and deviations on the production floor.
• Participate in facility walkthroughs, internal audits, and regulatory inspections.
• Ensure effective communication across departments to maintain high quality and compliance standards.

Skills

Quality Assurance

GMP compliance

cGMP

Quality systems

FMEA

SAP

TW

Education

Bachelor's degree in Life Sciences/Pharmaceutical Sciences/Biotechnology or related field

Tools

SAP

TW

Job description

Senior QA Specialist – Pharmaceutical Manufacturing

Swisslinx AG Vacant since : 10.11.2026 8001 Zürich (ZH) 45% By agreement Temporary

Join a leading pharmaceutical manufacturing project as a Senior QA Specialist, ensuring GMP compliance, quality operations and tech transfer.

We are looking for an experienced Senior QA Specialist to join a major pharmaceutical manufacturing project in Visp, Switzerland.

In this role, you will be responsible for supporting Quality Assurance operations throughout commissioning, qualification, and technology transfer activities, ensuring compliance with GMP standards and internal quality procedures.

Key Responsibilities

• Manage project-specific QA Operations activities during commissioning, qualification, and technology transfer phases.
• Assess and manage quality-related activities that may impact GMP manufacturing operations.
• Coordinate with cross-functional teams, including Quality Control, Engineering, and Manufacturing, to ensure timely execution of planned activities.
• Support daily Quality Assurance operations in accordance with established SOPs, policies, and GMP requirements.
• Review GMP documentation and manufacturing records to ensure compliance with cGMP standards and approved procedures.
• Make timely, risk-based quality decisions regarding manufacturing events and deviations on the production floor.
• Participate in facility walkthroughs, internal audits, and regulatory inspections.
• Ensure effective communication and collaboration across departments to maintain high quality and compliance standards.

About the customer

Our client is a leading global organization in the pharmaceutical and biotechnology industry, specializing in the development and manufacturing of innovative healthcare solutions. With a strong presence in Switzerland, the company operates state-of-the-art manufacturing facilities and supports complex projects in a highly regulated GMP environment.

Requirements

• Bachelor's degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, or a related field.
• Significant professional experience in pharmaceutical Quality Assurance or a closely related quality function.
• Proven experience in Quality Assurance, Manufacturing, or Engineering within a cGMP-regulated pharmaceutical environment.
• Solid understanding of GMP regulations, quality systems, and pharmaceutical manufacturing processes.
• Experience reviewing GMP documentation and ensuring compliance with established SOPs and quality standards.
• Strong knowledge of computerized systems used in pharmaceutical environments, such as SAP, TW, or similar platforms.
• Proficiency in quality risk management methodologies and tools, including FMEA (Failure Mode and Effects Analysis).
• Ability to make independent, quality-focused decisions in a dynamic manufacturing environment.
• Strong organizational, communication, and cross-functional collaboration skills.
• Fluent English, both written and spoken.

Nice to Have

• Previous QA experience supporting technology transfer projects within pharmaceutical manufacturing.
• Experience with commissioning and qualification activities in GMP-regulated facilities.
• Familiarity with large-scale pharmaceutical manufacturing projects, including facility start-up or production readiness activities.
• Previous involvement in GMP inspections and regulatory audits.

• Swisslinx AG
  Löwenstrasse 29
  8001 Zürich

• Work location 8001 Zürich (ZH)
• Workload 45%
• Employment start By agreement
• Employment duration Temporary
• By online Online form