QA Operations team is committed to actively support Celgene International manufacturing site and other departments to ensure cGMP compliant production, testing and release of product on the Boudry
manufacturing site.
This position 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 be responsible for the assigned processes and activities within QA Operations and will act as member of the Bulk production and Quality Control Support team.
The activities include responsibility for execution of the main following processes: deviation and CAPA, change control handling, QA oversight of validation and qualification activities.
Additional tasks are batch record review, release of raw materials for production, risk assessments, as well as the support of health authorities’ inspections and corporate audits.
The Specialist, QA Operations can be assigned special tasks in cross-functional projects to support Boudry manufacturing site activities like new product introduction and launches.
This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, ensure lean release of bulk product, raw materials for
production, as well as to contribute to process improvement in his/her scope of activity.
Duties and Responsibilities
Supports the deviations and CAPA process by handling deviations and CAPA and executing investigations within assigned areas of responsibility.
Supports the change control process. Performs action plan evaluation and coordinates change control progress within assigned areas of responsibility.
Reviews and approves as QA representative qualification and validation activities documents (protocols, reports…).
Perform batch record review and prepare batch release documentation.
Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.
Represents QA within department and cross-functional project teams according to assignments.
Acts as backup for colleagues within QA Operations team.
Skills/Knowledge Required
At least 3 years of experience in a pharmaceutical company or other related industry.
BS or MSc in Science or related field.
Good understanding of cGMPs and FDA regulatory requirements.
Good understanding of solid oral dosage form manufacturing processes and QC testing methods are preferred.
Proven interpersonal, collaborative and organizational skills.
Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
Ability to focus attention to details.
Good written & oral communication skills.
Investigational and problem-solving skills.
Knowledge of most common office software (Microsoft Office).
About Us
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
