Quality Control Manager (f/m/d)

Coriolis Pharma Research GmbH

82152 Planegg - Deutschland

Qualitätsmanager/in Teilzeit Abend ab 04.11.2025

Beschreibung

### Purpose of your Job

As a member of the Quality Control Team at Coriolis Pharma, you will play a key role in ensuring compliance and excellence across qualification and validation activities. You will collaborate with Qualification Experts and System Owners to ensure that equipment qualification and computerized system validation are executed according to GMP regulations and internal procedures. Acting as an interface between the GMP operative team, QA, and IT, you will define validation strategies, manage the validation lifecycle, and ensure proper documentation and traceability. In this role, you will help ensure that all qualification and validation tasks are completed efficiently, effectively, and in full compliance with regulatory standards.

### Your Responsibility

Qualification & Validation Activities:

- Compile, review, and approve instrument qualification documentation.
- Release equipment for GMP use after successful completion of qualification projects in collaboration with QA.
- Compile, review, and approve risk assessments related to equipment qualification.
- Ensure that all qualification and validation documentation complies with internal SOPs and regulatory expectations.
- Support handling of (equipment-related) changes, deviations, CAPAs, SST failures, risk assessments, and OOS cases.

Analytical Method Validation & Lifecycle Management:

- Compile, review, and approve analytical method validation and verification documentation.
- Provide validation support for technology transfers and process changes.
- Collaborate with analytical teams during method validation projects to ensure robust and compliant outcomes.
- Support the GMP analytical team in defining validation strategies and managing the lifecycle of analytical methods.
- Assess validation needs during technology transfers or when introducing new processes.

Continuous Improvement & Compliance:

- Monitor industry trends and regulatory updates to refine validation strategies.
- Provide technical guidance and training on validation requirements and procedures.
- Support internal and external audits as well as authority inspections to ensure readiness and compliance.

### What you need to succeed

- Master’s degree or equivalent in Biology, Chemistry, Pharmacy, or another field of natural science; PhD preferred
- Documented training in GMP regulations, Quality Management Systems, equipment qualification, and method validation
- Minimum 3 years of professional experience in equipment qualification and method validation within a regulated biopharmaceutical environment
- Strong knowledge of GMP and qualification/validation guidelines, with hands-on experience in compiling and reviewing qualification and validation protocols and reports
- Familiarity with risk assessment tools and compliance of computerized systems
- Excellent documentation skills with high attention to detail and accuracy
- Exceptional analytical and problem-solving abilities, combined with the capacity to manage multiple projects in a fast-paced, team-oriented setting
- Excellent communication and interpersonal skills, with fluency in English, both written and spoken

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