We are currently looking for a junior Quality Manager (m/f/d) for our pharma client
Volume: 40 hrs / week
Location: Remote /Monheim
Language: English / German (at least Reading capability)
The goal of this function is to support the Quality Management Systems elements, including but not limited to the following:
- To ensure global quality practices are integrated in the affiliate to ensure compliance is met with regard to client and local regulations.
- To maintain the GXP status of the affiliate in accordance with national and international GMP and legal requirements.
- To ensure QA deliverables are achieved in a compliant timely manner.
- To support Local German Quality Team in the ordinary and extraordinary tasks.
Goal: Ensure implementation and maintenance of the local Quality Management System elements listed below in order to drive compliance of all relevant cGXPs with local/International regulatory requirements and clients global standard operating procedures.
• Support Deviation management and temperature excursion
management (reported by 3PL Movianto)
• Issuance of local PQR assessments, including the local PQR assessments for Products where the German Affiliate is MAH outside Germany (EU MAH)
• Support activities resulting from legal obligations as MAH
(update white paper “MAH Project)
• Support local Complaint activities / monthly reporting
• Support local Talent Share learning coordinator activity
• Support Management of Incoming Goods check at Austrian
• Minimum of three years working experience in the
pharmaceutical industry in a GMP environment
• Self-motivated team player
• Must be able to effectively interact with internal and
external personnel on quality related matter
• Good knowledge of the English language (both written and
• Good knowledge of the German language (at least in
We are excited to hear from you
Michael Bailey International is acting as an Employment Business in relation to this vacancy.