QA Senior Specialist - 7168

CTC Resourcing Solutions; Oberwallis; Presencial; CHF 90.000 - 130.000; Jornada completa

Descripción de la vacante

CTC Resourcing Solutions client, a leading pharmaceutical company, seeks a QA Senior Specialist to support commissioning, qualification and technology transfer activities. You will ensure GMP compliance, provide operational QA support, review GMP documentation, and coordinate across QC, Engineering and Manufacturing to maintain quality standards on projects.

This 8-month contract offers exposure to cGMP environments and internal audits with real-time quality decision-making on the manufacturing

Formación

• Bachelor's degree in Life Sciences or related field.
• Significant experience in Quality Assurance within the pharmaceutical industry.
• Experience in QA, Production or Engineering in a GMP-controlled environment.
• Experience supporting technology transfer activities is highly preferred.
• Excellent knowledge of TrackWise and SAP.
• Good understanding of quality risk management tools and methodologies, particularly FMEA.
• Strong coordination and communication skills across multiple departments.

Responsabilidades

• Lead and support project-specific QA activities during commissioning, qualification and technology transfer.
• Assess, manage and coordinate quality-related activities that may impact GMP manufacturing operations.
• Plan and coordinate upcoming quality activities with QC, Engineering, Manufacturing and other departments.
• Provide day-to-day QA support within a GMP manufacturing environment, ensuring compliance with SOPs and quality policies.
• Review GMP documentation and manufacturing records for GMP compliance and procedures.
• Make real-time quality decisions regarding process events and deviations on the manufacturing floor.
• Participate in facility walkthroughs, internal audits and regulatory inspections.

Conocimientos

Quality Assurance

Cross-functional coordination

Communication

Regulatory compliance

Educación

Bachelor's degree in Life Sciences

Herramientas

TrackWise

SAP

FMEA

Descripción del empleo

Our client, a leading company in the pharmaceutical industry, is looking for a QA Senior Specialist to support project-specific Quality Assurance activities during commissioning, qualification and technology transfer activities.

The successful candidate will ensure GMP compliance, provide operational QA support and collaborate closely with cross-functional teams to maintain quality standards throughout manufacturing and project activities. It's a 8 months contract.

Responsibilities :

• Lead and support project-specific QA activities during commissioning, qualification and technology transfer.
• Assess, manage and coordinate quality-related activities that may impact GMP manufacturing operations.
• Plan and coordinate upcoming quality activities in collaboration with QC, Engineering, Manufacturing and other relevant departments.
• Provide day-to-day Quality Assurance support within a GMP manufacturing environment, ensuring compliance with approved SOPs and quality policies.
• Review GMP documentation and manufacturing records to ensure compliance with cGMP requirements and established procedures.
• Make real-time quality decisions regarding process events and deviations on the manufacturing floor, based on applicable SOPs and quality policies.
• Participate in facility walkthroughs, internal audits and regulatory inspections.

Required Skills & Qualifications :

• Bachelor's degree in Life Sciences or a related scientific discipline.
• Significant experience in Quality Assurance within the pharmaceutical industry.
• Previous experience in QA, Production or Engineering within a pharmaceutical GMP-controlled environment.
• Experience supporting technology transfer activities is highly preferred.
• Excellent knowledge of computerized systems such as TrackWise and SAP.
• Good understanding of quality risk management tools and methodologies, particularly FMEA.
• Strong coordination and communication skills, with the ability to collaborate effectively across multiple departments.