Compliance QA Specialist Pharmaceutical Manufacturing
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Job Location:
Monthly Salary:
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
Our partner is a stable internationally established pharmaceutical company engaged in pharmaceutical manufacturing. The Compliance QA Specialistis 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
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
- 510 years of relevant pharmaceutical industry experience in Quality Assurance or Compliancein 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 worklife 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 .
Required Experience:
IC
