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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

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Job type: Permanent

Discipline: Good Distribution Practice (GDP)

Location: Switzerland

A fantastic opportunity has arisen for a Compliance Specialist in Solothurn. This position will partner with Compliance leaders from the EU region to ensure overall compliance through internal audit process.

Job Responsibilities

Conduct and lead Internal Audit as per company Internal Audit schedule and assess compliance with local, national, international and company regulations, policies and procedures
Support inspection readiness plan within EU region against EU MDR in high collaboration with site compliance partners and business partners.
Collect metrics data from sites.
Use of tracking and trending tools in order to share proactive trends/signal to the compliance leader.
Support Compliance improvements, which result from audits, Quality Board Issues and other system indicators
Work effectively with the Source Compliance team and other site compliance specialist to ensure consistent systems across the organization.
Ensure proper internal audit reporting, response review and approvals, communication of issues.
When required assist given facilities for both external audit preparation and assistance during their external audit

Skills and Requirements

Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485/EU MDR) within a regulated environment
At least 5 years working experience in a regulated Medical Device industry
Experience in a quality and/or compliance function as well as leading performing audits is required
Excellent Communication Skills (written & oral) in English - German would be a plus

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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