Country: Hungary
Functional area: Quality Assurance & Quality Control
Our partner is a stable, internationally established pharmaceutical company engaged in pharmaceutical manufacturing. The Compliance QA Specialist is a key member of the central Quality and Audit organization, responsible for overseeing GxP compliance across global manufacturing sites, monitoring regulatory trends, and supporting health authority inspections. This role acts as a bridge between global quality expectations and local operational execution within a complex pharmaceutical production environment.

Key Responsibilities
  • Provide expert support to global pharmaceutical manufacturing sites and internal projects to ensure ongoing GxP compliance.
  • Ensure alignment with global QMS requirements.
  • ​​​​​​​Actively participate in the preparation and execution of international health authority inspections (e.g., FDA, EMA). 
  • Contribute to the development of responses, corrective actions, and remediation plans. 
  • Plan and execute internal GxP audits across manufacturing operations.
  • Participate in the corporate auditor program, including occasional external audits.
  • Continuously track changes in the pharmaceutical regulatory landscape.
  • Perform gap assessments and propose updates to the global QMS.
  •  Design, document, and harmonize global quality processes and workflows across manufacturing sites.
  •  Collect, analyze, and report compliance KPIs to Quality leadership.

 Requirements
​​​

  • 5–10 years of relevant pharmaceutical industry experience in Quality Assurance or Compliance, in a manufacturing environment.
  • Strong knowledge of cGMP regulations (FDA 21 CFR, EU GMP Annexes).
  • Experience with quality systems and software (e.g., TrackWise, SAP, or similar document management systems).
  • Operational experience in pharmaceutical manufacturing is an advantage.

What We Offer
​​​​​​

  • Option for full remote work or hybrid setup based on candidate preference.
  • Transparent, people-focused culture with strong emphasis on work–life balance.
  • Opportunity to participate in global compliance initiatives and gain international lead auditor experience.
  • A solid, internationally recognized company with a strong growth trajectory.

Interested?

If this opportunity resonates with you, please upload your CV or contact Zsolt Bódi directly at zsbodi@carbyne.hu.

Our partner is a stable, internationally established pharmaceutical company engaged in pharmaceutical manufacturing. The Compliance QA Specialist is a key member of the central Quality and Audit organization, responsible for overseeing GxP compliance across global manufacturing sites, monitoring regulatory trends, and supporting health authority inspections. This role acts as a bridge between global quality expectations and local operational execution within a complex pharmaceutical production environment.

Key Responsibilities

  • Provide expert support to global pharmaceutical manufacturing sites and internal projects to ensure ongoing GxP compliance.
  • Ensure alignment with global QMS requirements.
  • ​​​​​​​Actively participate in the preparation and execution of international health authority inspections (e.g., FDA, EMA). 
  • Contribute to the development of responses, corrective actions, and remediation plans. 
  • Plan and execute internal GxP audits across manufacturing operations.
  • Participate in the corporate auditor program, including occasional external audits.
  • Continuously track changes in the pharmaceutical regulatory landscape.
  • Perform gap assessments and propose updates to the global QMS.
  •  Design, document, and harmonize global quality processes and workflows across manufacturing sites.
  •  Collect, analyze, and report compliance KPIs to Quality leadership.

 Requirements
​​​

  • 5–10 years of relevant pharmaceutical industry experience in Quality Assurance or Compliance, in a manufacturing environment.
  • Strong knowledge of cGMP regulations (FDA 21 CFR, EU GMP Annexes).
  • Experience with quality systems and software (e.g., TrackWise, SAP, or similar document management systems).
  • Operational experience in pharmaceutical manufacturing is an advantage.

What We Offer
​​​​​​

  • Option for full remote work or hybrid setup based on candidate preference.
  • Transparent, people-focused culture with strong emphasis on work–life balance.
  • Opportunity to participate in global compliance initiatives and gain international lead auditor experience.
  • A solid, internationally recognized company with a strong growth trajectory.

Interested?

If this opportunity resonates with you, please upload your CV or contact Zsolt Bódi directly at zsbodi@carbyne.hu.