Celgene Quality Assurance Compliance Intern in BOUDRY, NebraskaSwitzerland
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Celgene International QA is committed to actively support the Celgene International manufacturing site and other departments to ensure cGMP compliant processes and qualification/validation activities on the Boudry Manufacturing site.
The position holder is responsible for quality assurance (QA) involved primarily with the support of the different Quality System tools in place to ensure cGMP compliance throughout the Boudry Manufacturing Site.
The position holder will provide support in all QA compliance activities on the manufacturing Site (Deviations/CAPA, Product Quality Complaints, Change Controls, Annual Product Review, Supplier Management...)
The QA Compliance Intern can be assigned special project tasks (Project Work).
Duties & responsibilities :
The position holder is responsible and accountable for the tasks given below. The list of tasks is non exhaustive, according to business needs other tasks might be assigned to the position holder.
a. Supports the deviations and CAPA process by handling deviations and CAPA and executing investigations within assigned areas of responsibility, under guidance from QA Compliance team members.
b. Supports the change control process. Performs action plan evaluation and coordinates change control progress within assigned areas of responsibility, under guidance from QA Compliance team members.
c. Supports the product quality complaints process by handling complaints and executing investigations as assigned, under guidance from QA Compliance team members.
d. Supports the supplier qualification process by assisting in material supplier and vendor evaluation and approval.
e. Supports the generation of annual product reports
f. As a member of the Quality Operations team, position holder will be working closely with the QA Compliance team members to identify and handle product /process quality and cGMP compliance related issues/improvements
g. The QA Compliance Intern can be assigned other particular tasks (e.g. Project Work), based on required business needs and support to stakeholders of the Quality Operations department.
Skills & knowledge required :
• Minimum: on going BSc in Science, Engineering or Technical discipline.
• Some experience in pharmaceutical industry for QA/QC-related function is an asset
• Knowledge of international GxP regulations, 21CFR11, and good documentation practices.
• Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
• Excellent Interpersonal, collaborative and organizational skills.
• Ability to focus attention to detail.
• Ability to work independently and effectively in a team
• Knowledge of most common office software (Microsoft Office)
• Good communication skills (written and verbal) in French
• Good knowledge in English.
Quality Assurance Compliance Intern
Location: BOUDRY, NE, CH
Job ID: 17001178