Celgene Specialist, QA eSystems in BOUDRY, NebraskaSwitzerland
Celgene International Quality Operations is committed to actively support the Celgene International II site in Couvet and other departments to ensure cGMP compliant processes and products. To enforce and manage the sub-processes associated with QA, several QA eSystems (IT applications) are locally operated by Quality Operations.
This position is responsible for QA eSystems maintenance, support and local administration in coordination with the support of the QA eSystems Celgene International Sàrl team. The position holder will also be asked to support the QA eSystems team of Celgene International Sàrl in Boudry.
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:
Will act as superuser/admin as required for the following systems, eQRMS (all modules in use at by Celgene International and Celgene International II), FileTrail, LiSI, Celdox, Oracle, QUADS and other systems as they are rolled out within the responsibility of the Quality Operations group
Will perform the review and approval of master data for the PTM process within the Oracle EBS System.
Will work with the local and global PTM Oracle MDM teams to maintain improve the procedures and processes related to Oracle EBS MDM
Is responsible to handle deviations, CAPA, and Change Control related to eSystems of Celgene International II (as required will also be involved in the handling of records for Celgene International) and to ensure the execution and the follow up of escalation processes up to both Celgene International and the global level.
Represents QA eSystems within project teams per assignment and will handle validation documentation QA review as required for IT systems for Celgene International
Writes and assists with writing of SOPs, WPs etc for QA eSystems.
Will participate as required in project teams for changes and improvements in the Oracle EBS application
Will participate as required in testing of changes made to the Oracle EBS application
Organizes cGMP compliant eSystems management and user trainings.
Participates in global project teams for the roll out of new global QA eSystems and takes responsibility for assigned tasks e.g. to plan, coordinate and execute activities related to the local implementation of new global QA eSystems.
Support transfers of new eSystems to Celgene International II Sàrl and/or Celgene International Sàrl
Supports the Manager, QA eSystems, and the QA Compliance groups with investigations, root cause analyses and CAPA definition as needed and appropriate
At least 3 years of experience in Quality Control, Quality Assurance and/or IT 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 and QC processes.
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 English and French.
Good interpersonal and training skills.
Ability to focus and an attention to details.
Knowledge of most common office software (Microsoft Office etc).
Specialist, QA eSystems
Location: BOUDRY, NE, CH
Job ID: 17001269