Quality Assurance Specialist

Roquette

. Drive quality excellence and continuous improvement across the Stade and Bomlitz sites by identifying improvement opportunities, further developing the Quality Management System (QMS), promoting a GMP culture, and supporting quality optimization projects at both locations.

Posted 9/17/2026full-timeStade • GermanyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Quality Management Systems (QMS), GMP compliance, and risk assessment methodologies, while effectively supporting operational QA activities and cross-functional improvement projects. Proficient in CAPA, Change Control, and validation processes, with strong communication skills in both German and English.

Highest-signal resume keywords

Quality Management System (QMS)GMP ComplianceCAPA ManagementRisk AssessmentValidation and Qualification

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality AssuranceRisk AssessmentValidationQualificationCAPAChange ControlAudit ManagementGMP TrainingContinuous ImprovementRoot-Cause Analysis

Soft Skills

CollaborationCommunicationProblem-Solving

Tools & Technologies

SAP

Certifications & Qualifications

EXCiPACT GMPIPEC-PQG GMPFSSC 22000HACCP

Industry Keywords

PharmaceuticalFood IndustryExcipient

About the role

Key responsibilities & impact

Drive quality excellence and continuous improvement across the Stade and Bomlitz sites by identifying improvement opportunities, further developing the Quality Management System (QMS), promoting a GMP culture, and supporting quality optimization projects at both locations.
Lead analyses and improvement projects, including conducting risk assessments, supporting qualification and validation activities, and contributing to cross-functional improvement and harmonization initiatives.
Support Production by providing operational QA support and contributing to deviations, complaints, CAPAs, Change Controls, root-cause analyses, and batch release activities.
Promote compliance and a strong quality culture by participating in audits, delivering GMP training, and acting as a trusted quality partner for Operations.
Drive Quality Excellence and Continuous Improvement across the Stade and Bomlitz sites.
Strengthen the QMS and promote GMP culture.
Manage risk assessments and support qualification and validation activities.
Contribute to cross-functional improvement and harmonization projects.
Provide operational QA support for deviations, complaints, CAPA, Change Controls, root-cause analyses and batch release activities.
Participate in audits, deliver GMP training and act as a trusted quality partner to Operations.

Requirements

What you’ll need

Bachelor’s or Master’s degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Food Science, Engineering, or a related discipline.
3–5 years of experience in Quality Assurance or a related quality function within the pharmaceutical, excipient, or food industry.
Knowledge of Quality Management Systems (QMS).
Knowledge of EXCiPACT GMP / IPEC-PQG GMP.
Knowledge of FSSC 22000 and HACCP.
Experience with CAPA, Change Control, and audit management.
Knowledge of qualification and validation.
SAP experience is an advantage.
Native-level or equivalent German proficiency, both written and spoken, is required.
Good English skills for collaboration in an international environment.
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Microbiology, Biotechnology, Food Science, Engineering or related discipline.
3–5 years in Quality Assurance or a related quality discipline within pharmaceutical, excipient or food industries.
Technical knowledge of QMS, EXCiPACT/IPEC-PQG GMP, FSSC 22000, HACCP, CAPA, Change Control, audits, validation and qualification.
German native speaker or equivalent level required, written and spoken.
Operational English required to collaborate effectively within the international organization.

Benefits

Comp & perks

Diverse learning and development opportunities in an innovative, entrepreneurial environment.
Access to internal development and career opportunities through our internal mobility policy.
Flexible working conditions to support a healthy work–life balance.
The opportunity to actively shape the quality culture at two strategic sites.
Opportunities to learn and grow within an entrepreneurial environment that fosters innovation.
Access to our internal mobility policy.
The ability to balance work and personal life through organizational flexibility.