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Quality assurance compliance expert

Neuenburg
Panda International
EUR 120’000 pro Jahr
Inserat online seit: 11 März
Beschreibung

Job Description

A global life sciences organisation is seeking an experienced QA Compliance Expert to ensure excellence in GMP Self-Inspection activities, data integrity, and quality project deployment at the Neuchâtel facility. This role reports to the Head of Quality Compliance and Systems and requires strong expertise in GMP compliance, internal audits, and quality systems. The QA Compliance Expert will partner with cross-functional teams across Production, Quality Control, Warehouse, and Engineering/Maintenance to maintain and enhance inspection readiness, continuous improvement, and compliance alignment.

The QA Compliance Expert will also act as the local Data Integrity Champion, support internal and external audits, and serve as a back-up to the Head of Quality Compliance and Systems when needed.


Qualifications

* University degree in a technical/scientific discipline such as Biochemistry, Chemistry, Engineering, or equivalent
* Minimum 7 years of experience in the biotechnology and/or pharmaceutical industry
* Strong knowledge of GMP and data integrity principles (Good Data and Documentation Practices – GDDP)
* Proven experience in creating, reviewing, and revising Standard Operating Procedures (SOPs) and technical documents
* Experience supporting regulatory inspections and audits
* Familiarity with risk management tools and methodologies (e.g., FMEA, root cause analysis)
* Proficiency in French and English (minimum B2 level)
* Proficiency with electronic quality management systems (e.g., Veeva Vault, TrackWise)
* Strong skills in Microsoft Office (Word, Excel, PowerPoint, SharePoint) and data analysis/reporting tools, including Power BI
* Ability to coach and support cross-functional teams on inspection readiness and compliance topics
* Demonstrated experience in leading continuous improvement initiatives


Preferred Requirements

* Prior experience in a biologics or complex pharmaceutical production environment
* Experience benchmarking practices across sites or facilities
* Proven ability to coordinate operational activities within a compliance team


Practicalities

* Start Date: ASAP
* Team: Collaborates with Quality Compliance and Systems Department
* Leadership: Acts as back-up for Head of Quality Compliance and Systems when needed
* Scope: Site-level responsibility with alignment across global biologics network

Interested? Send your CV to Miguel Gomes at m.gomes@panda-int.com or call +31 (0)20 2044 502 / +41 (0)44 5514 407 to discuss the opportunity.

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