Quality Auditor

We are hiring for a Quality Auditor at our MSD site in Boxmeer

Responsibilities:

• The Quality Auditor conducts routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations.
• Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
• In addition, the Auditor communicates and resolves audit comments with client areas. Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
• Issue reports summarizing deficiencies and work with areas to execute remedial action. Notify appropriate management of inspection result. Position will receive direction and support.

Qualifications:

• Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.
• Effective communications (oral/written) and interpersonal skills are necessary.

This is a temporary position, more information will be provided upon application