Freelance Quality Compliance Consultant (m/f/d)
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Upper Austria, Austria |
Freelance
Consultant – Pharmaceutical Compliance & Documentation (m/f/d)
Type: Freelance / Contracting Location: UpperEastern Austria (travel required) | Remote work possible (~50%) Start: Mid-August or early September 2026 Duration: approx. 6 weeks Workload: approx. 170–180 hours
About the Project
We are looking for an experienced compliance consultant to assist with a documentation compliance review at a production site. The core task is to conduct a structured comparison of the local site documentation with the registered dossiers—with a focus on identifying discrepancies, changes, and gaps in documentation.
Since this is an international assignment, all reports and results will be in English.
Your Responsibilities
- Comparing local production documentation with the registered dossiers
- Reviewing regulatory approval documents against local documents (specifications, manufacturing procedures)
- Reviewing up to 6 dossiers
- Identifying and documenting changes between current and registered documentation
- Processing of electronic documentation (approx. 50% of the total volume)
- Preparation of reports and findings in English
What You Bring to the Table (Must-haves)
- Proven experience in regulatory affairsand/or quality assurance in the pharmaceutical industry
- In-depth knowledge of dossier structures and GMP documentation requirements
- Experience with document reconciliation and change management in a regulated environment
- Professional command of English (written and spoken)
- Willingness to travel to the production site
Languages
- English: Required – professional proficiency in both written and spoken English
- German: An asset, but not required—candidates who speak only English are also welcome
Reference number: 17704
Industry: Pharmaceutical Industry
Project start: 24.07.2026
Duration: 6 weeks
Employment type: Freelance
Contact
Alexander Brzezowsky