Quality Assurance Compliance Specialist Jobs in Greater Munich Metropolitan Area at K-Recruiting Life Sciences

Title: Quality Assurance Compliance Specialist

Company: K-Recruiting Life Sciences

Location: Greater Munich Metropolitan Area

Quality Assurance Compliance Consultant (m/f/d)

Responsibilities

Provide consulting support and recommendations for the implementation and optimization of processes at the interface between Regional Quality and Site Quality, with a focus on release management.
Create and maintain drafts for customer- and country-specific release specifications and certificate requirements.
Support country release activities in coordination with Quality Assurance, Supply Chain Management, Production, and Packaging.
Conduct EU MAH assessments for global changes and deviations within the scope of consulting projects.
Evaluate supplier impacts related to partner-proposed changes (e.g. expansion into new markets).
Review Product Technical Specifications (PTS).
Prepare and update SOP drafts and Quality Agreements (QAAs) for internal approval processes.
Support the timely and GMP-compliant handling of deviations, complaints, CAPAs, and change controls through analysis, documentation, and corrective action recommendations.
Act as a subject matter expert for compliance-related topics within project environments for internal and external stakeholders.
Coordinate professionally with the responsible Qualified Person (QP).

Qualifications

Degree in Life Sciences (e.g. Pharmacy, Chemistry, Biology) or a comparable qualification preferred.
Several years of professional experience in a GMP-regulated environment with a strong focus on Quality Assurance and Compliance (e.g. deviation and complaint management, CAPA processes, change control, OOX investigations).
Several years of experience in Quality Assurance within sterile biopharmaceutical manufacturing environments, preferably involving ADC or mAB production, is considered a strong advantage.
In-depth knowledge of regulatory requirements and guidelines (EU-GMP, ICH guidelines, ideally FDA regulations).
Experience working with electronic Quality Management Systems (e.g. TrackWise Digital).
Experience with SAP/S4 HANA.
Strong quality and compliance mindset.
High attention to detail and a structured, documentation-focused way of working.
Strong analytical and problem-solving skills.
Ability to independently prioritize tasks and provide sound professional recommendations.
Excellent communication skills in professional stakeholder environments.
Fluent German and English skills, both written and spoken.

General Conditions

Qa Hired