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.
- 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 correctly
- Provide 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 skills
- Dedication to high quality and motivation to work in an international and dynamic environment.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.