Quality Assurance Engineer

vor 1 Monat

Zürich, Schweiz Michael Page Vollzeit

Our client, a leading international player in the consumer goods industry with modern offices in the Zurich area, is looking for a Quality Assurance Engineer (m/f/d) to start immediately in a temporary assignment for the next 12 months.

Depending on the motivation, as well as on the performance of the selected candidate there might be an opportunity for an extension.

Description

The Quality Assurance Engineer (m/f/d) focuses on leading quality improvement projects using statistical tools and problem-solving methods to meet our client's quality standards.

The selected candidate provides technical support to quality assurance and ensures credibility across the organization.

On the compliance side, the Quality Assurance Engineer implements policies and manages the GMP document control system, oversees compliance programs, conducts internal audits, supports external audits, and delivers GMP training, all while ensuring regulatory adherence and consumer satisfaction.

  • Implement and enforce policies, procedures, and standards.
  • Conduct internal audits, document findings, and ensure audit readiness.
  • Stay updated on GMP regulations, guidelines, and best practices.
  • Oversee validation activities with vendor or global compliance team (IQ/OQ/PQ).
  • Manage compliance programs, monitor trends, and coordinate investigations as needed.
  • Support data integrity guidelines.
  • Serve as site expert for GMP documentation, change control, and CAPA systems.
  • Manage the document control process for batch records, SOPs, protocols, and investigations.
  • Lead Quality function during new product trials.
  • Coordinate investigations of customer/consumer complaints.
  • Ensure CAPA completion and effectiveness.
  • Escalate critical issues as necessary.
  • Support decisions on out-of-spec materials.
  • Provide expertise for RFT goals and improvement initiatives.
  • Coordinate with external groups on quality issues (Operations, Labs, Vendors, etc.).
  • Develop and implement a standardized GMP training process.
  • Collaborate with site leaders to create training programs based on roles.
  • Track and report training metrics.

Profile

For this challenging and rewarding position, the ideal candidate should have: ·

  • Successfully completed bachelor's degree, ideally in chemistry, logistics or quality
  • Minimum 3-4 years of working experience in a regulated industry is required, with FMCG, chemistry or pharmaceutical experience
  • Strong background in quality system improvement and process design.
  • Expertise in GMP regulations (ISO22716, FDA, KFDA); OTC manufacturing knowledge is a plus.
  • Knowledge of statistical sampling, AQL/ANSI, and specification/drawing interpretation.
  • Ability to review SOPs, GMP, and batch records.
  • Proficiency in Microsoft Office, QMS, SAP; Six Sigma is a plus.
  • Proven experience in root cause analysis and CAPA.
  • Solid English, as well as very good German skills.
  • Skilled at process improvements with cross-functional teams.
  • Strong communication skills for diverse stakeholders.

Job Offer

  • Excellent opportunity to be part of a highly qualified QA team with a regional scope.
  • Gaining experience in a Distribution Center environment.
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