Document Control Lead

We are seeking an experienced Document Lead to work across multiple tasks within the Quality Assurance Team, providing your expertise when needed.

Job Responsibilities

Lead and coordinate the Document Control team member(s) engaged in processing quality system documents through routing, reviews and approvals.Understand FDA and ISO Document Control requirements and ensure that the Company's global Document Control procedures and practices meet these requirements.Partner with IT to ensure that the eQMS meets the quality system requirements and company's needs.Ensure that quality system documents are issued and changed. Verify that the documents were properly routed for approval and archived according to the Company's Document Control procedures.Review documents for format, document changes, required attachments, enter applicable fields in the e-QMS and ensure that they are completed correctlyProvide e-QMS training for our employees, issue eQMS training tools if needed.

Skills and Requirements

Commercial degree with at least 2-3 years' experience in a similar role, preferably within Document Control.Experience in the Medical Device field as well as leadership skills are highly desired.Excellent English skills, both written and spoken with very good grammar knowledge for proofreading.Very good German and/or French skills are a plus.Proficient IT Skills (MS Office, Visio, Adobe Acrobat, etc.)Excellent organization and communication skillsDedication to high quality and motivation to work in an international and dynamic environment.

To Apply

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

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