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.
This position is responsible for QA eSystems maintenance, support and local administration in coordination with and support of the QA eSystems Celgene International Sàrl team. Additionally the position holder ensures cGMP compliance for the QA eSystems by organizing necessary system activities and planning/executing user trainings. The position holder may also be asked to support the QA eSystems team of Celgene International Sàrl in Boudry.
Additionally to the support of the local QA eSystems, the position holder will be responsible to support the implementation and roll-out of the global QA eSystems on the Celgene International II Sàrl manufacturing site.
Furthermore the position holder will collaborate with the IT validation group to ensure adequate validation of the local network applications for the QA eSystems.
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:
• Supports the design, review and approval of Master Batch Records and Master Data for the PTM process within the Oracle EBS System,
• Participates in global project teams for the roll out of new global QA e-Systems and takes responsibility for assigned tasks e.g. to plan, coordinate and execute activities related to the local implementation of new global QA e-Systems.
• Is the superuser / first point of contact for the QA Operations team for QA eSystems
• Is responsible for creating a local maintenance process for the relevant eSystems, as directed; these activities include training of super users/local administrators,
• Writes and assists with writing SOPs for and QA approval of documentation for QA eSystems.
• Organizes cGMP compliant eSystems management and user trainings,
• Is responsible to handle deviations, CAPA, and Change Control related to eSystems of Celgene International II and to ensure the execution and the follow up of escalation processes up to both Celgene International and the global level,
• Handles qualification documentation (DQ, IQ, OQ, PQ) of eSystems for QA review,
• Supports execution of qualifications (FAT, SAT, DQ, IQ, OQ, PQ) for eSystems
Skills and knowledge required:
• 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 and of IT-principles.