Celgene Associate Specialist, Quality Assurance in Boudry, Switzerland
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.
1 Year Contract
The Quality Assurance Associate Specialist will report administratively and functionally to the Manager, Quality Assurance.
The primary role of the Quality Assurance Associate Specialist is to perform routine quality assurance tasks and activities ensuring compliance with all regulatory and corporate requirements
In addition, this position will assist in the development, organization, and execution of the Quality Assurance Management system of Celgene Ext QA within the Global Quality Organization which will ensure product quality and compliance with all regulatory and corporate requirements for Celgene Products within Europe and Rest of World Markets as applicable. Products may be for investigational or commercial use.
BSc (or equivalent) in a technical or scientific discipline
Demonstrated pharmaceutical quality experience (equivalent to a minimum of 5 years experience) including audit, batch record review, change control, complaint handling and investigations experience
Knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly)
Demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance
Strong task management skills with the ability to prioritize, schedule, and control multiple projects and resources simultaneously under tight deadlines
Excellent communication skills, including excellent written, interpersonal, collaboration, and negotiation skills, with a team oriented approach
Problem solving and organizational skills
Attention to detail
Duties and Responsibilities
Responsibilities include, but are not limited to, the following:
For the assigned products and area of Celgene Global Quality Operations and International Quality Operations:
Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements. This includes
Building and maintaining good working relationships with the contractor
Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, OOS records, processes, methods, procedures, documentation, etc.
Recommending quality related improvements to the contractor
Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
Manage change control requests. This includes, as necessary:
Initiating and approval routing of change control requests
Performing QA evaluation and endorsement/approval
Review of associated contractor change control requests
Monitoring progress of related action items
Escalation of change controls to Global Change Control as required.
Process product complaints. This includes, as necessary:
Recording complaint details
Contacting complainant for additional information and/or to request samples
Initiating manufacturing investigation
Communicating conclusion to complainant
Performing and monitoring trend analyses and reporting to upper management
Review, edit, negotiate improvements to, and approve contractor documentation, including:
Process validation protocols and reports
Transfer validation protocol and reports
Investigations, Deviations, OOS records
Author Product Quality Review reports, as necessary. Or, review, edit, negotiate improvements to contractor supplied Product Quality Review reports.
Develop and maintain Reference Master Files
Draft or review, negotiate with contractors, and recommend approval for Quality Agreements
Participate in self inspections as appropriate
Participate in external audits of contractor manufacturers and distributors as assigned
Ensure logs, databases and files related to the product quality activities are maintained
Performance of trend reviews and compilation of metrics
For non-product related duties:
Develop and/or maintain pharmaceutical quality systems, as assigned
Author and/or revise standard operating procedures and associated work instructions, as assigned
Review and provide recommendations on policies and standards, as assigned
Support GMP/GDP site inspections, as assigned
Maintain compliance with personal training requirements
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.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE