Quality Assurance Specialist

Discover International; Berlin; On-site; EUR 60,000 - 90,000; Full time

Job summary

Discover International is seeking a Quality Assurance Specialist to oversee deviation management within its GMP Quality Management System. You will ensure deviations are documented, investigated, assessed and closed timely, coordinating with QA, QC, Manufacturing, Engineering and other stakeholders.

The ideal candidate has 3+ years in GMP-regulated QA, strong root cause analysis, CAPA leadership and good documentation practices. English fluency is required; German is a plus.

Qualifications

• Bachelor’s or Master’s in biotech/chemistry/pharma or equivalent.
• Min 3 years GMP QA, deviation management, CAPA experience.
• Strong root cause analysis and risk assessment skills.
• Knowledge of GMP documentation practices and regulatory expectations.
• Excellent written communication and cross‑functional collaboration.
• Fluent English; German is a plus.

Responsibilities

• Oversee end‑to‑end deviation lifecycle from initiation to closure.
• Lead root cause investigations using structured methods.
• Assess deviation impact on product quality, safety and data integrity.
• Coordinate cross‑functional investigations with multiple departments.
• Define and monitor CAPAs, ownership, timeliness and effectiveness.
• Ensure deviations/CAPAs are documented and traceable.
• Prepare deviation reports and risk assessments for reviews and inspections.
• Support internal and external audits and inspections.
• Provide deviation reporting training and GMP documentation guidance.
• Drive continuous improvement of the Quality Management System.

Skills

GMP knowledge

QA experience

Deviation management

CAPA

Root cause analysis

Documentation

Cross-functional coordination

Biotech/Pharma

Education

Bachelor's/Master's in biotech/pharma

Tools

QMS platforms

Job description

Experience: 3+ years in GMP-regulated Quality Assurance / Quality Systems

I have partnered with an emerging biopharmaceutical company focused on the development and manufacturing of advanced biologics and complex molecules.

The Opportunity

We are seeking a Quality Assurance Specialist to oversee and continuously improve deviation management processes within its GMP Quality Management System.

This role will be responsible for ensuring that deviations are appropriately documented, investigated, assessed and closed in a timely and compliant manner. Working closely with Quality Assurance, Quality Control, Manufacturing, Engineering and other cross-functional stakeholders, you will drive robust investigations, effective CAPAs and sustainable corrective and preventive actions.

This position is well suited to a Quality professional who enjoys problem-solving, investigating complex issues and improving processes within a growing biopharmaceutical environment.

Key Responsibilities

• Manage the end-to-end deviation lifecycle, including initiation, triage, classification, impact assessment, investigation, review, approval and closure.
• Lead and facilitate root cause investigations using structured methodologies such as 5 Whys, Fishbone/Ishikawa and other appropriate investigation tools.
• Assess the potential impact of deviations on product quality, patient safety, data integrity, validated processes and GMP compliance.
• Coordinate cross-functional investigations with Manufacturing, QC, QA, Engineering, Validation and other relevant departments.
• Define, manage and monitor Corrective and Preventive Actions (CAPAs), ensuring appropriate ownership, implementation, documentation and effectiveness checks.
• Ensure deviations and associated CAPAs are completed within established timelines, escalating overdue or critical quality issues where required.
• Identify recurring deviations and adverse trends through quality metrics, periodic reviews and trend analysis.
• Prepare deviation reports, investigation summaries, risk assessments and supporting documentation for internal review and external inspections.
• Maintain and improve deviation management procedures, SOPs, workflows and investigation standards.
• Support internal audits, customer audits and regulatory inspections, including the preparation and presentation of deviation and CAPA records.
• Provide guidance and training to employees on deviation reporting, investigation techniques, root cause analysis and GMP documentation practices.
• Drive continuous improvement initiatives to strengthen the effectiveness and efficiency of the Quality Management System.

Requirements

• Bachelor's or Master's degree in Biotechnology, Biology, Chemistry, Pharmaceutical Sciences or a related scientific discipline, or equivalent relevant experience.
• At least 3 years of experience in GMP-regulated Quality Assurance, deviation management, investigations, CAPA or Quality Systems.
• Good understanding of GMP requirements and Good Documentation Practices.
• Practical experience managing deviations, investigations and CAPAs within a pharmaceutical or biotechnology environment.
• Experience with root cause analysis, risk assessment and quality event trending.
• Strong written documentation, analytical thinking and problem-solving skills.
• Confident communication skills with the ability to coordinate investigations across multiple departments.
• Ability to manage competing priorities and drive quality events towards timely resolution.
• Experience in biologics manufacturing or a cleanroom environment would be advantageous.
• Familiarity with electronic QMS platforms and quality metrics reporting is a plus.
• Fluent English is desirable; German language skills would be an advantage, subject to final role requirements.

Working model: Primarily on-site, with some flexibility subject to agreement.