Quality Assurance GMP Manufacturing Specialist
Job Title: Quality Assurance (QA) Specialist
Location: DACH
Job Type: Freelance / Contract
Department: Manufacturing
Role Overview
The QA GMP Manufacturing Specialist is responsible for providing quality oversight and ensuring compliance with current Good Manufacturing Practices (cGMP) during manufacturing operations. This role supports clinical and/or commercial manufacturing by reviewing batch records, overseeing manufacturing activities, managing deviations and CAPAs, and ensuring product quality, data integrity, and regulatory compliance in a biotech or pharmaceutical manufacturing environment.
Key Responsibilities
GMP Manufacturing Oversight
* Provide on-the-floor QA support for GMP manufacturing operations, including drug substance and/or drug product manufacturing.
* Perform real-time review and approval of manufacturing activities to ensure compliance with cGMPs, internal procedures, and regulatory requirements.
* Support manufacturing campaigns, including shift or on-call coverage as required.
Batch Record Review & Product Disposition
* Review executed batch production records, logbooks, and associated documentation for accuracy, completeness, and GMP compliance.
* Participate in batch release activities, including review of deviations, investigations, and supporting documentation.
* Ensure timely product disposition in alignment with quality and business objectives.
Deviations, Investigations & CAPA
* Lead or support deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
* Ensure investigations are thorough, timely, and compliant with regulatory expectations.
* Track and trend quality events to identify systemic issues and drive continuous improvement.
Change Management & Documentation
* Review and approve change controls impacting manufacturing processes, equipment, facilities, and documentation.
* Review and approve GMP documentation including SOPs, manufacturing instructions, protocols, and reports.
* Ensure documentation practices meet data integrity and ALCOA+ principles.
Regulatory & Compliance Support
* Support internal and external audits, inspections, and regulatory submissions as needed.
* Serve as a QA representative during FDA, EMA, or other regulatory authority inspections.
* Ensure manufacturing operations remain inspection-ready at all times.
Required Skills & Qualifications
* Proven experience within a manufacturing environment
* GMP experience
* Strong understanding of QA methodologies, tools, and best practices
* Excellent attention to detail and problem-solving skills
* Ability to work independently and manage deadlines in a freelance environment
* Strong written and verbal communication skills
* Project-based or ongoing work, depending on performance and availability
Either apply here directly or email your CV to (alex.oneal@meetlifesciences.com)
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