Senior QA Specialist – Pharmaceutical Manufacturing (GMP)

Swisslinx AG; Zürich; On-site; CHF 120,000 - 150,000; Full time

Job summary

Swisslinx AG is seeking a Senior QA Specialist to join a major pharmaceutical manufacturing project in Visp, Switzerland. You will support quality assurance operations across commissioning, qualification, and technology transfer, ensuring GMP compliance and adherence to internal procedures.

The role requires strong GMP knowledge, experience in cGMP, and hands-on QA activities with cross-functional teams. Fluent English and the ability to make independent, risk-based decisions on manufacturing

Qualifications

• Bachelor's degree in Life Sciences or 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.
• 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 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.

Skills

GMP regulations

Quality Assurance

ERP systems (SAP/TW)

FMEA

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in Life Sciences or related field

Tools

SAP

TW

Job description

Senior QA Specialist – Pharmaceutical Manufacturing (GMP)

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

Job description:

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.