QA Associate

Discover International; Zürich; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

26 days annual leave

Birthday day off

Zusammenfassung

Discover International is seeking a proactive Quality Assurance Specialist to join our biotech team in Zurich. With 2–6 years in GMP-regulated environments, you will broaden your expertise across QMS, compliance, supplier quality, and audits, while contributing to a robust quality culture.

You will collaborate with Quality, Production and QC to sustain the site's QMS, support inspections, and drive continuous improvement in a fast-paced biotech setting.

Qualifikationen

• 2–6 years of QA experience in GMP-regulated pharma/biotech.
• Strong familiarity with QMS and quality records.
• Knowledge of Swissmedic/EMA/FDA is advantageous.
• Excellent documentation and record-keeping skills.
• Ability to work independently and collaborate across departments.

Aufgaben

• Maintain and improve the site's Quality Management System (QMS).
• Prepare, review, approve, and archive controlled quality documents (SOPs, work instructions, templates, quality records).
• Manage quality events including deviations, change controls, CAPAs, and OOS investigations.
• Review batch documentation and quality control records for GMP compliance.
• Coordinate training records and maintain training matrix.
• Support supplier qualification activities and supplier documentation.
• Assist with internal and regulatory audits and inspections.
• Support regulatory submissions with quality documents.
• Review equipment qualification and cleanroom documentation.
• Collaborate with cross-functional teams to drive continuous quality improvements.

Kenntnisse

QMS management

Deviations & CAPAs

Change Controls

Batch documentation review

GMP regulations awareness

Regulatory documentation

Attention to detail

Independent teamwork

English fluency

Ausbildung

Bachelor's or Master's in Biology/ Biotechnology/ Pharmaceutical Sciences/ Chemistry

Jobbeschreibung

We are seeking a proactive and detail-oriented Quality Assurance Specialist to join an innovative biotech organisation. This is an exciting opportunity for a quality professional with 2–6 years of experience in a GMP-regulated pharmaceutical or biotechnology environment who is looking to broaden their expertise across Quality Management Systems, compliance, supplier quality, and audit support.

Working closely with Quality, Production, and Quality Control teams, you will play a key role in maintaining the site's Quality Management System, ensuring regulatory compliance, supporting inspections, and contributing to continuous improvement initiatives within a fast-paced biotech environment.

Key Responsibilities

• Maintain and continuously improve the site's Quality Management System (QMS).
• Prepare, review, approve, and archive controlled quality documentation, including SOPs, Work Instructions, Templates, and quality records.
• Manage quality events including Deviations, Change Controls, CAPAs, and Out of Specification (OOS) investigations.
• Review and maintain batch documentation, controlled production records, and Quality Control documentation to ensure GMP compliance.
• Coordinate training records and maintain the site's training matrix.
• Support supplier qualification activities, including supplier documentation, paper-based audits, and qualification tracking.
• Assist with internal audits, customer audits, regulatory inspections, and CAPA follow-up activities.
• Support regulatory submissions through the preparation and compilation of quality documentation.
• Review qualification documentation for equipment and cleanroom facilities.
• Collaborate with cross-functional teams to drive quality improvements and maintain inspection readiness.

Candidate Profile

• Bachelor's or Master's degree in Biology, Biotechnology, Pharmaceutical Sciences, Chemistry, or another relevant scientific discipline.
• 2–6 years of Quality Assurance experience within a GMP-regulated pharmaceutical or biotechnology environment.
• Strong experience working with Quality Management Systems (QMS), including Deviations, CAPAs, Change Controls, and batch documentation review.
• Good understanding of GMP regulations; experience within biologics manufacturing is highly desirable.
• Familiarity with Swissmedic, EMA, and FDA regulatory requirements is advantageous.
• Excellent documentation, organisational, and record-keeping skills with strong attention to detail.
• Ability to work independently while collaborating effectively across multiple departments.
• Fluent English is essential; German is advantageous.

What's on Offer

• Join a fast-growing biotech company making a meaningful impact on patients' lives.
• Opportunity to work within a collaborative, innovative, and highly motivated team.
• Exposure to a broad range of QA activities in a dynamic GMP manufacturing environment.
• Excellent professional development opportunities within a rapidly expanding organisation.
• 26 days' annual leave, plus an additional day off for your birthday.

Please note: This position is primarily site-based and includes occasional weekend support as required.