Senior QA Lead – GMP Pharma Manufacturing & Tech Transfer

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

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.