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.
Skills / Knowledge Required
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 responsible for the review of master and executed batch records (API, bulk, semi-finished and finished products), validation, bill of materials, packaging masters.
b. Handles 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,
c. Supports the design, review and approval of Master Batch Records and Master Data for the PTM process within the Oracle EBS System,
d. Writes and assists with writing SOPs, WPs, FORMs, and further documents for QA.
e. Handles qualification and validation documentation (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation), for QA review
f. Supports execution of qualifications and validations (FAT, SAT, DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation, QC Method validation),
g. Handles 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.
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. Ensures successful Authorities inspections by participating in the preparation and the support in different roles (i.
e. Backoffice, Subject Matter Expert, Scribe or Runner),
k. Support QC / QA transfers of new products / methods to Celgene International II,
l. Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility.