Quality Assurance Specialist

EPM Scientific; Berlin; Vor Ort; EUR 40.000 - 55.000; Vollzeit

Zusammenfassung

EPM Scientific is supporting a global leader in dietary supplements, pharmaceutical products, and functional foods west of Berlin, Germany. The Quality Assurance Specialist will support GMP compliance, supplier management, and continuous improvement within a regulated manufacturing environment.

The role collaborates with Quality, Production, Purchasing and external suppliers to uphold quality processes and audit readiness.

Qualifikationen

• Understanding of GMP principles and quality management systems.
• Knowledge of food safety standards or pharmaceutical quality regulations is desirable.
• Experience managing quality documentation and compliance processes.

Aufgaben

• Ensure GMP-compliant manufacturing and quality activities align with policies.
• Maintain and improve the site's Quality Management framework.
• Manage supplier quality activities including risk assessments and onboarding.
• Support supplier oversight programmes and external quality reviews as needed.
• Coordinate audits and supplier qualification activities.
• Prepare, review and maintain quality system documentation (SOPs,Quality Agreements).
• Assist investigations of quality issues and non-conformances with corrective actions.
• Collaborate across operations, procurement and quality to ensure compliance.
• Drive quality improvement projects for operational excellence and readiness.
• Provide guidance on quality standards across the organization.

Kenntnisse

GMP knowledge

Quality management systems

Supplier management

Quality documentation

Ausbildung

Pharmaceutical Sciences

Food Technology

Life Sciences

Quality Management

Related technical discipline

Jobbeschreibung

Quality Assurance Specialist - Entry Level

Location: West of Berlin, Germany
Working Pattern: Full-Time, On-Site
Industry: Pharmaceutical Manufacturing

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About the Opportunity

EPM Scientific is supporting a global leader in the development and manufacture of dietary supplements, pharmaceutical products, and functional foods in the search for a Quality Assurance Specialist to join their growing team situated west of Berlin, Germany.
This position offers the opportunity to work within an internationally recognised organisation operating across Europe, Asia, and North America. The successful candidate will play a key role in maintaining quality standards, supporting supplier management activities, and ensuring compliance with GMP and regulatory requirements within a highly regulated manufacturing environment.
This is an excellent opportunity for quality professionals seeking to further develop their career within a business that values innovation, collaboration, and continuous improvement.

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The Position

As a Quality Assurance Specialist, you will support the maintenance and continuous improvement of the Quality Management System while ensuring compliance with internal policies, GMP requirements, and applicable regulatory standards.
You will work closely with cross-functional teams across Quality, Production, Purchasing, and external suppliers to maintain effective quality processes and support audit readiness across the business.

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Key Responsibilities

• Ensure manufacturing and quality activities operate in line with GMP expectations, regulatory requirements, and company quality policies.
• Support the ongoing enhancement and effectiveness of the site's Quality Management framework.
• Manage supplier quality activities, including risk assessments, onboarding, and performance monitoring.
• Contribute to supplier oversight programmes and participate in external quality reviews where required.
• Support inspection readiness by coordinating activities related to customer, certification, and third-party audits.
• Prepare, review, and maintain quality system documentation, including procedures, quality arrangements, governance documents, and controlled records.
• Assist with the investigation of quality issues, customer concerns, and non-conformances, ensuring appropriate actions are implemented and tracked to completion.
• Partner with cross-functional teams across operations, procurement, and quality functions to promote compliance and process efficiency.
• Drive quality and compliance improvement projects aimed at strengthening operational excellence and regulatory readiness.
• Provide guidance and support on quality-related matters to ensure consistent application of quality standards throughout the organisation.
• Support the implementation and maintenance of GMP requirements, legal regulations, and internal quality standards.
• Contribute to the continuous development and improvement of the Quality Management System.
• Coordinate supplier evaluations and support supplier qualification activities.
• Participate in supplier audits and ongoing supplier management programmes.
• Assist with the preparation, coordination, and execution of customer, certification, and supplier audits.
• Create, review, and maintain quality-related documentation including:
  o Quality Agreements
  o Responsibility Agreements
  o Standard Operating Procedures (SOPs)
  o Work Instructions
  o Quality Management documents
• Support complaint investigations and quality event management activities.
• Collaborate with internal stakeholders to ensure compliance and operational excellence.
• Support continuous improvement initiatives to strengthen quality performance across the site.

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Candidate Profile

• Equivalent experience gained within a food, nutraceutical, pharmaceutical, or regulated manufacturing environment.
• Previous experience within Quality Assurance, Quality Systems, Quality Operations, or regulated manufacturing environments.
• Exposure to contract manufacturing organisations (CMOs/CDMOs) would be advantageous.
• o Completed vocational training within:
• o Pharmaceutical Sciences
• o Food Technology
• o Life Sciences
• o Quality Management
• o Or a related technical discipline
• OR
• * Equivalent experience gained within a food, nutraceutical, pharmaceutical, or regulated manufacturing environment.
• * Previous experience within Quality Assurance, Quality Systems, Quality Operations, or regulated manufacturing environments.
• * Exposure to contract manufacturing organisations (CMOs/CDMOs) would be advantageous.
• * Experience supporting audits, supplier management, or quality documentation activities is preferred.

Technical Knowledge

• * Understanding of GMP principles and quality management systems.
• * Knowledge of food safety standards or pharmaceutical quality regulations is desirable.
• * Experience managing quality documentation and compliance processes.

Language Requirements

• * Fluent German language skills.
• * Strong English communication skills, both written and verbal.