Validation and Compliance Expert
1 dia atrás
Are you passionate about quality and compliance? Do you want to make a difference in the pharmaceutical industry? We are seeking a highly motivated and experienced individual to join our team as a Senior Quality Manager. In this role, you will be responsible for ensuring Hovione's facilities, equipment, and supporting systems meet applicable quality standards. You will work collaboratively with colleagues to support the design of test strategies and methodologies for qualification and validation applications.
Responsibilities
The successful candidate will be responsible for defining and implementing procedures and processes to ensure Hovione facilities, equipment, and supporting systems meet applicable quality standards. They must assure cGMP compliance in activities related to Qualification and Validation throughout their lifecycle. Key responsibilities include coaching/training Sites' Quality and Operational areas, promoting a culture of continuous improvement, and reviewing/proposing changes to corporate procedures that regulate Qualification and Validation activities.
Requirements
The ideal candidate will have advanced knowledge of Quality, Engineering, cGMP, ICH, and ISO guidelines. They must have the ability to solve complex problems and conduct tasks in accordance with rules and procedures. Fluency in English is required, and computer literacy with good working knowledge of the MS Office package is essential. Typically, the successful candidate will have 5-8 years of relevant experience in Quality and Qualification and Validation.
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