Couvet, Neuchatel, Switzerland Job Category:
Quality Work Location:
Rue du Pr-Jorat 14 2108 Organization:
Quality Operations Employee Status:
Full-time Job Type:
What unique gene will you bring to Celgene?
On the QA Operations team, we deliver our mission by supporting the Celgene International II site and other departments to ensure cGMP compliant processes and products. This position is responsible for quality assurance (QA) involved primarily with the review of bulk and packaged commercial drug products, API batches if required, and maintaining working relationships with QA departments at contract facilities. The position will support QA activities (deviation, CAPA, OOS, change control, risk management, audit, inspections...) on the Celgene International II Srl manufacturing site of Couvet. As a key member of the Quality Operations team, this position will be expected to be a reliable source of information and interpretation of quality and cGMP compliance requirements. The position holder may also be asked to support the Quality Operations team of Celgene International Srl in Boudry. For the project phase of the Couvet's plant, the position holder, jointly with the QA team, will support the project team as Quality Operations interface responsible of all GMP topics (regulations, quality systems, training) and further support the development of the team to sustain the start-up, licensure, and commercial phases.
- At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
- BSc/BA (or equivalent) in Life Sciences or a related discipline.
- Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
- Solid understanding of solid oral dosage form manufacturing/packaging processes and QC testing methods.
- Works independently, yet effectively in a team environment.
- Excellent investigational skills and QA problem-solving skills has a keen eye for Quality.
- Excellent written & oral communication skills in both French and English.
- Good interpersonal and training skills.
- Ability to focus attention to details.
- Knowledge of most common office software.
As the QA Operations Specialist, you'll support that goal by....
About Us COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
- Reviewing of executed batch records (API, raw materials, bulk, semi-finished and finished products).
- Handling deviations, CAPA, and Change Control related to Celgene International II and to ensure the execution and the follow up of escalation processes up to both Celgene International and the global level,
- Writing and assists with writing SOPs, WPs, FORMs, and further documents for QA.
- Handling qualification and validation documentation (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation), for QA review
- Supporting execution of qualifications and validations (FAT, SAT, DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation),
- Handling in cooperation with Corporate Quality the approval and qualification of suppliers of bulk drug products, quality control laboratories, packaging services and packaging materials including participation to auditing and establishing Technical/Quality Agreements.
- Handling in collaboration with Celgene International Quality Organization, the approval of GMP Material suppliers for the Celgene International II production site and ensures periodic evaluation of GMP Material Suppliers as required in collaboration with Celgene International GMP/GDP audit function.
- Supporting the internal GMP-audits process including the yearly internal audit plans, the writing of audit reports (paper or electronically) and the follow-up and the implementation of the internal audit CAPAs.
- Ensuring successful Authorities inspections by participating in the preparation and the support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe or Runner),
- Supporting QC/QA transfers of new products/methods to Celgene International II,
- Ensuring that all regulations concerning product security and all established working methods are respected within the area of responsibility.
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.