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.
· At least 5 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry.
· BS in Science, or related field.
· 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 written & oral communication skills in both French and English.
· Excellent investigational and QA problem solving skills.
· Ability to focus attention to details.
· Knowledge of most common office software and of IT-principles.
Duties and 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.
The position holder:
a. Is the local SME for the deviation handling, investigation and CAPA processes,
b. Is responsible to handle deviations, OOS and CAPA of Celgene International II and from external contract partners as assigned and ensures the execution and the follow up of escalation processes up to the global level,
c. Supports the design of Master Batch Records for bulk pharmaceutical drug product, semi-finished and finished pharmaceutical drug product,
d. Supports the Change Control management: monitoring, reporting, and active management with the team and the related functions of Celgene International II of the actions of local Change Controls,
e. Handles qualification and validation documentation (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation), for QA review
f. Supports execution of qualification and validation (FAT, SAT, DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation),
g. Handles in cooperation with Corporate Quality & Compliance 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.
h. Handles 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.
i. Supports 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.
j. Supports the compilation of the Annual Quality Review Report and the Product Quality Review according the Swiss-, EMEA- and FDA-requirements for the products under the responsibility of Celgene International II, as assigned.
k. Participates to Celgene audits and visits to external manufacturers/suppliers as assigned.
l. Ensures successful Authorities inspections by participating in the preparation and the support in different roles (i.e. Backoffice, Subject Matter Expert, Scribe or Runner).
m. Support QC/QA transfers of new products / methods to Celgene International II.
n. Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility.
o. Has a participation on the recruitment process of new members of the team as requested.
p. Assigns tasks to direct reports in accordance with their responsibilities and capabilities.
Provides continuous support and adequate coaching to ensure direct reports fulfill their duties and objectives. Assures continuous professional development and guidance to direct reports.
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.