Quality Manager - GDP - Munich
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 email@example.com.
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.
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 firstname.lastname@example.org
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