QA Manager

headcount AG; Zürich; Hybrid; CHF 140.000 - 180.000; Vollzeit

Zusammenfassung

headcount AG in the Zürich area seeks an experienced QA Manager / Senior Quality Assurance Specialist to oversee GMP manufacturing activities focusing on Drug Substance. The role is hands-on and requires coordinating deviations, investigations and CAPAs, with batch review and release responsibilities.

Fluent German is essential alongside good English, and you will work closely with manufacturing, quality and external partners in a 60% onsite hybrid model in the Zürich area.

Qualifikationen

• Around 5+ years of QA experience within pharma/biotech
• Strong experience in Manufacturing QA
• Drug Substance manufacturing knowledge preferred; Drug Product experience considered
• Hands-on with deviations, investigations, CAPAs, Change Controls and Quality Risk Assessments
• Experience supporting batch review and/or release activities
• Strong knowledge of GMP and pharmaceutical Quality Management Systems
• Experience working closely with manufacturing operations
• Scientific/technical background in Chemistry, Pharmaceutical Sciences, Laboratory Technology or related
• Fluent German – mandatory
• Good command of English
• Currently based in Switzerland

Aufgaben

• Provide hands-on QA support for GMP manufacturing activities
• Support batch review and batch release activities
• Lead and coordinate deviations, investigations and CAPAs
• Perform and document Quality Risk Assessments
• Support Change Control activities
• Review, revise and prepare GMP and Quality documentation
• Independently organise and drive Quality investigations
• Provide QA support to manufacturing operations
• Support regulatory inspections and inspection-readiness activities
• Collaborate with internal stakeholders and external contract service providers
• Ensure compliance with applicable GMP requirements and Quality Systems

Kenntnisse

Quality Assurance

GMP manufacturing

Deviations & CAPAs

Batch review & release

Change Controls

Quality Risk Assessments

QMS knowledge

Manufacturing operations

German language

English communications

Jobbeschreibung

We are looking for an experienced QA Manager / Senior Quality Assurance Specialist to join an international pharmaceutical company in the Zürich area.

This is a hands-on Quality Assurance role supporting GMP manufacturing activities, with a strong focus on Drug Substance. You will work closely with Manufacturing, Quality and external partners and independently manage operational QA activities.

Fluent German is essential for this position, alongside good English communication skills.

Key Responsibilities

• Provide hands-on Quality Assurance support for GMP manufacturing activities
• Support batch review and batch release activities
• Lead and coordinate deviations, investigations and CAPAs
• Perform and document Quality Risk Assessments
• Support Change Control activities
• Review, revise and prepare GMP and Quality documentation
• Independently organise and drive Quality investigations
• Provide QA support to manufacturing operations
• Support regulatory inspections and inspection-readiness activities
• Collaborate with internal stakeholders and external contract service providers
• Ensure compliance with applicable GMP requirements and Quality Systems

Your Profile

• Around 5+ years of Quality Assurance experience within the pharmaceutical or biotechnology industry
• Strong experience in Manufacturing Quality Assurance
• Good understanding of Drug Substance manufacturing is highly preferred; relevant Drug Product experience will also be considered
• Hands-on experience with deviations, investigations, CAPAs, Change Controls and Quality Risk Assessments
• Experience supporting batch review and/or release activities
• Strong knowledge of GMP and pharmaceutical Quality Management Systems
• Experience working closely with manufacturing operations
• Scientific or technical background, ideally in Chemistry, Pharmaceutical Sciences, Laboratory Technology or a related discipline
• Able to independently lead investigations and Quality activities
• Methodical, structured and highly organised working styleFluent German – mandatory
• Good command of English
• Currently based in Switzerland

Working Model This is a 100% position requiring approximately 60% onsite presence in the Zürich area.

Approximately three days per week onsite are expected, with Tuesday and Thursday as mandatory onsite days.