QA Officer Corporate

DFE Pharma GmbH & Co. KG

Deutschland

Remote

EUR 60.000 - 85.000

Vollzeit

14 Tage+
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Benefits dieser Stelle

Flat structure
International environment
Head office Goch
Continuous learning

Zusammenfassung

DFE Pharma, a leading excipient supplier, seeks a QA Officer to safeguard and continuously improve the quality system across multi-site CMO and QC activities. You act as a central QA contact for external partners and provide hands-on support to QA topics, ensuring compliance with IPEC cGMP, ISO 9001, and regulatory requirements.

You will collaborate with cross-functional teams and internal stakeholders, reporting to the QA Operations Manager.

Qualifikationen

  • Minimum bachelor’s degree (HBO) in (bio)chemistry, pharmaceutical sciences, Health & Life Sciences, or a related field.
  • At least 4 years of relevant experience in the pharmaceutical or food processing industry, including at least 2 years in QA.
  • Knowledge of ISO 9001, IPEC cGMP, and GMP guidelines; advanced skills in MS Office, SAP, and electronic documentation systems (e.g., MasterControl).
  • Fluent in Dutch and English (spoken, written, and reading).
  • Strong analytical skills; pragmatic, structured, and proactive approach.
  • Results‑oriented, resilient, a team player, and equipped with excellent communication skills.
  • Affinity with AI tools, such as Microsoft Copilot.

Aufgaben

  • Ensure QA oversight for CMO activities, including review and approval of quality documentation.
  • Support and coordinate deviation management, complaint handling, and investigations related to CMO and QC activities.
  • Provide QA support to QC, including release-related activities and compliance topics.
  • Initiate and monitor corrective and preventive actions (CAPA) and support changes within Change Control.
  • Assess, release, and follow up on raw materials, excipients, packaging materials, and finished products, including coordination of deviation management and complaint investigations.
  • Actively contribute to an ESG‑driven culture by working in accordance with company‑wide Environmental, Social & Governance guidelines.

Kenntnisse

QA oversight
Deviation management
CAPA
Change Control
Release activities
Analytical skills
Communication skills
Team player
Affinity with AI tools

Ausbildung

Bachelor’s degree (HBO) in (bio)chemistry, pharmaceutical sciences, Health & Life Sciences, or related field

Tools

MS Office
SAP
MasterControl

Jobbeschreibung

DFE Pharma is a leading international manufacturer of excipients for the pharmaceutical industry. Our products are used worldwide and are known for their high quality, reliability, and consistent performance.

At DFE Pharma, we look for professionals who demonstrate ownership, take responsibility, and actively contribute to continuous improvement within an international, quality-driven organisation.

You will be working in an environment where quality, collaboration, independence, and professional development are central. As part of a motivated, cross-functional team, you will make a visible contribution to the further development of our quality organisation.

As a QA Officer, you play a key role in safeguarding and continuously improving the quality system within DFE Pharma, with a specific focus onCMO activities and support to QC Nijmegen.

You act as a central QA contact for external manufacturing partners and provide hands-on support to QC-related quality topics. You ensure that processes and products meet the highest standards such as IPEC cGMP, ISO 9001, and applicable regulatory requirements, while maintaining a pragmatic and business-oriented approach.

This is a multi-site role, requiring close collaboration across functions and locations. You will regularly engage with internal stakeholders and external partners to ensure alignment, compliance, and continuous improvement.

  • Ensure QA oversight for CMO activities, including review and approval of quality documentation.
  • Support and coordinate deviation management, complaint handling, and investigations related to CMO and QC activities.
  • Provide QA support to QC, including release-related activities and compliance topics.
  • Initiate and monitor corrective and preventive actions (CAPA) and support changes within Change Control.
  • Assess, release, and follow up on raw materials, excipients, packaging materials, and finished products, including coordination of deviation management and complaint investigations.
  • Actively contribute to an ESG‑driven culture by working in accordance with company‑wide Environmental, Social & Governance guidelines.
What we ask
  • Minimum bachelor’s degree (HBO) in (bio)chemistry, pharmaceutical sciences, Health & Life Sciences, or a related field.
  • At least 4 years of relevant experience in the pharmaceutical or food processing industry, including at least 2 years in QA.
  • Knowledge of ISO 9001, IPEC cGMP, and GMP guidelines; advanced skills in MS Office, SAP, and electronic documentation systems (e.g., MasterControl).
  • Fluent in Dutch and English (spoken, written, and reading).
  • Strong analytical skills; pragmatic, structured, and proactive approach.
  • Results‑oriented, resilient, a team player, and equipped with excellent communication skills.
  • Affinity with AI tools, such as Microsoft Copilot.
What we offer
  • Working at a company that is market leader in excipient solutions.
  • Continuous learning and development; your development is not only good for your career; we also benefit from it.
  • A flat organisation structure with short communication and short decision lines.
  • International and dynamic work environment.
  • You report to the QA Operations Manager.
  • The role is based at the head office in Goch, close to the Dutch border.
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