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| QC Incoming & External Analyses Manager |
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To manage the QC Raw Materials testing & External Analysis laboratory and ensure that all related activities (raw material and utilities testing, sampling activities and external analysis management) are performed in accordance with the cGMPs and regulatory requirements
To ensure a consistent customer focused analytical service to Merck Serono Aubonne and Vevey, to guarantee the supply of quality products according to the established plan, good manufacturing practices, product registration, site quality standards, and manage within agreed financial limits
To ensure the use of validated/qualified analytical methods and equipment
To ensure the availability of a reliable and accurate documentation in the laboratory
To support the transfer or implementation of new analytical test methods
To support the transfer of production processes including trials and validation batches according to company needs
To be the point of reference on the site for all incoming and external analysis activities
To drive or participate to the continuous improvement programs in the laboratory, department and site
To generate the analytical part of the registered files in collaboration with the regulatory functions |
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Bachelors Degree
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5 years + |
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French : Speak / Write Fluently
English : Speak / Write Fluently
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open-ended |
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unspecified |
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International |
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Vaud Vevey |
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Experience in raw materials, utilities testing and sampling activities in relation with Biotechnology / Aseptic processing (min. 5 years)
Experience in managerial positions
Experience in validation of analytical methods and technology transfer of analytical methods
Sound awareness of pharmaceutical business
Sound awareness of cGMP related issues and health authorities requirements and pharmacopoeias requirements concerning raw materials and utilities testing
Demonstrated success in process improvements
Demonstrated success in position, which interacts with other departments and functions
Must master and demonstrate ability to use computer and project management systems
Fluent in French and English.
Strong leadership and influencing skills. Strong managerial skills. Results orientation.
Competencies in budget establishment and cost control monitoring programs.
Strong interpersonal skills and ability to interact positively and constructively with all functions in a matrix organization environment. |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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