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Quality Manager (m/f/d)

Description

We are currently looking for a junior Quality Manager (m/f/d) for our pharma client

Start: ASAP
End: 31.12.22
Volume: 40 hrs / week
Location: Remote /Monheim
Language: English / German (at least Reading capability)

Tasks:

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
Affiliate

Skills:
• 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
spoken)
• Good knowledge of the German language (at least in
reading)

We are excited to hear from you

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Quality Manager (m/f/d)