Senior QMS Specialist

Hobson Prior are looking for a Senior QMS Specialist to join a global pharmaceutical organisation who provide innovative products and services for patients living with chronic kidney failure. You will be based in Frankfurt on a permanent basis.

Job Responsibilities:

• You will provide support in operating the document management system (processing DCR, DCCs and document change tasks).
• Render support in improving the document management process and related activities with focus on low complexity, efficiency and compliance.
• Host and take minutes in document management key meetings.
• Support local sites in training and implementing the document management system.
• Draft and deploy compliant SOPs and work instructions with training material on quality system process.
• Ensure compliant linkage of different quality sub-system processes undergoing update/change.
• Participate in document management process audits.
• First point of contact for the document control tool (QDOK).
• Conduct reporting and data analysis on the document management program effectiveness.

Key Skills:

• Team driven with the ability to build stakeholder relationships.
• Ability to challenge the status quo.
• Strong communication skills.
• High language proficiency in English (written and spoken).

Requirements:

• University degree (bachelors, or masters) or equivalent.
• Many years of proven professional experience in the medical or pharmaceutical industry within Quality Assurance.
• Knowledge of Quality Management System requirements and subsystem processes.
• Knowledge of document management software tools.
• Expertise in quality management standards (e.g. ISO13485, IS09001).
• Understanding of the medical device regulations (e.g. 21 CFR Part 820, RDC ANVISA 16/2013, MHLWM0169, TG (MD) R Sch3, CMDR, MDD 93/42/EC etc.), MDSAP program, EU guidelines for GMP, ICH Q10.
• Willingness to travel (domestic and abroad).

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.