Quality Manager - GDP - Munich

5 days left

Salary
On Application
Posted
30 Nov 2018
Closes
01 Mar 2019
Ref
JORDAN-Quality_Manager_GDP
Discipline
Quality, QA / QC

Quality Manager – GDP

Munich Area, Germany

€Excellent Salary + Benefits + Bonus

I am searching for talented individuals. For a confidential conversation call Louise Jordan:

+49 (0) 322 1421 9777 or email louise@umbilical-life.com.

Accountable for:

Overall responsibility as Quality Management Representative & Quality Manager, and for the coordination and compliance with GDP. Including the maintenance and development of the QMS documentation and processes.

  • Responsible for participating in Management Review Meetings, both on site and globally
  • Participate in regulatory as well as customer audits
  • Management of complaints and recalls
  • Carrying out internal audits, including participation in audits in the context of supplier and service provider qualification
  • Quality lead on new product introduction projects
  • Responsibility for adequate QA oversight and adequate GDP compliance at supplier sites
  • Active as the Quality contact for distributors of the company
  • The direct management for QMS processes including but not limited to:
    • Stock review and evaluation
    • Supplier and customer qualification
    • Qualification on transportation routes

The applicant will have the following Key Skills:

  • Good technical knowledge of EU GDP, including any additional local regulations and guidelines and be experienced in the operation on an EU regulatory approved QMS.
  • Knowledge of legal requirements according to AMG and AM-HandelsV
  • Computer skills, as necessary in routine operation, Microsoft Office: Word, Excel, Visio
  • Highly collaborative, regular interaction with the QA top management, Regulatory groups, QPPV, Supply chain, distributors, warehouses, sales departments, customers, MA holders and regulators.
  • Ability to work independently with limited supervision, self-driven, responsive and results orientated.
  • GDP auditing knowledge and practical skills, both hosting and performing.
  • Good team player, positive attitude and the ability to be flexible.
  • Ability to work under pressure in a fast moving work environment.

 

Qualifications:

A BCS degree in Life Science, with 5+ years of experience in Quality Assurance within wholesaling GDP in a Pharmaceutical environment, you will have;

  • Relevant GDP and RP training as required to discharge assigned duties and responsibilities
  • Knowledge of Narcotic Product local regulations desirable
  • Experience in Quality Management
  • Communication – excellent written and spoken English
  • Flexibility, a positive attitude and the ability to work in a fast-paced environment

 

For a confidential discussion please contact

Louise Jordan at Umbilical on

+49 (0) 322 1421 9777 or email louise@umbilical-life.com

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