393 days ago on approachpeople.com

Quality Assurance Project Manager - Freiburg area

Approach People Recruitment SA

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Quality Assurance Project Manager - Freiburg area

Job details

Category : Autres  |   Location : Fribourg

Quality Assurance Project Manager – Freiburg area

Date : 2016-04-22 04:53:52

As a team member of the Global Quality Assurance department, you are the primary Commercial Operations QA representative within the covered region for the commercial organization. You also lead operational Quality Assurance activities at suppliers for commercial biological molecules.

Your mission:
-Providing Quality Systems & technical support to commercial affiliates.
-Implementing and managing the QA System including its policies, procedures and programs as well as evaluating data and trends relevant to quality performance of corresponding affiliates/region;
-Assuring products distributed by the affiliates conform to Good Manufacturing Practices (GMP), quality standards and other regulatory standards.
-Developing and implementing quality principles at affiliates while minimizing disruptions to business, based on a robust quality risk assessment
-Monitoring compliance with policies and procedures in addition to all applicable regulatory requirements and industry standards
-Implementing and managing quality systems and training programs as necessary to support: Quality events, Validation, Physician sample handling, Inspection reporting and tracking, Policy implementation
-Developing and delivering training
-Providing overall technical and documentation support to commercial affiliates;
-Managing programs and projects as assigned by management;
-Providing guidance and support for all activities governed by Good Distribution Practices in the region
-Acting as a Region technical resource regarding quality systems and compliance.
Your profile:
- Master Degree in Life Sciences
- At least 5 years’ experience in the pharmaceutical biological industry in a GMP operational quality management role
- GMP Auditing Expertise
- Excellent communication skills, abilities to analyze data and to identify risks to suggest corrective actions.
- Fluent in English, French is a strong plus

Join a worldwide innovative company in the pharmaceutical sector by applying at selin@approachpeople.com


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