Quality validation manager
Akka Life Sciences - Bâle-Ville
16.05.2019 | Employee | 100%

The AKKA Technologies Group is a leading international Engineering and Technologies services company scattered in more than 20 countries around the world (Europe, Asia, Africa, America and Middle East) with over 21,000 employees and an annual turnover of 1.5b EUR.

To support the development of our activities, we are now looking for a:

 

Quality validation manager

Description of the project:

 

 

- Ensure compliance with Quality System and its underlying Good Manufacturing Practice (GMP) requirements

- Participate in the analysis and correction of deviations and their approval
- Support the change management process by reviewing and approving change requests
- Review and release of GMP relevant documents (eg work instructions / SOPs)
- Review and approval of qualification documents, in particular in the field of process automation (eg PLS, MES) and plant qualification
- Ensuring the conduct of the periodic review of the qualification status
- Specialist expert with regard to the quality system and participation in projects
- Participation in and assistance with official inspections and audits
- Verification and implementation of quality requirements, global standards and procedures

 

 

Skills:

 

 

- University degree in engineering or in a scientific field

- Knowledge in handling the common in the pharmaceutical industry PLS and MES systems and experience in the field of engineering and quality assurance
- Expertise in the qualification of process automation systems and production facilities
- Expertise in current Good Manufacturing Practice (cGMP) relevant to the pharmaceutical industry
- Good knowledge of the principles of quality assurance systems, as well as the practices and standards of the pharmaceutical industry (e.g., GAMP)
- Very good German and English

 

16.05.2019
Employee, 100%

Contact

Akka Life Sciences
Megan Holmstrom
Chemin de Blandonnet 8
1214 Vernier
No recruitment agencies please
Akka Life Sciences
Chemin de Blandonnet 8
Vernier

Industry

Consultancy
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