Celgene Specialist, QA eSystems in BOUDRY, NebraskaSwitzerland

Description

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 thefollowing systems, eQRMS (all modules in use at by Celgene International and CelgeneInternational II), FileTrail, LiSI, Celdox, Oracle, QUADS and other systems asthey are rolled out within the responsibility of the Quality Operations group

  • Will perform the review and approval of masterdata for the PTM process within the Oracle EBS System.

  • Will work with the local and global PTM OracleMDM teams to maintain improve the procedures and processes related to OracleEBS MDM

  • Is responsible to handle deviations, CAPA, andChange Control related to eSystems of Celgene International II (as requiredwill also be involved in the handling of records for Celgene International) andto ensure the execution and the follow up of escalation processes up to bothCelgene International and the global level.

  • Represents QA eSystems within project teams perassignment and will handle validation documentation QA review as required forIT systems for Celgene International

  • Writes and assists with writing of SOPs, WPsetc for QA eSystems.

  • Will participate as required in project teamsfor changes and improvements in the Oracle EBS application

  • Will participate as required in testing ofchanges made to the Oracle EBS application

  • Organizes cGMP compliant eSystems managementand user trainings.

  • Participates in global project teams for theroll out of new global QA eSystems and takes responsibility for assigned taskse.g. to plan, coordinate and execute activities related to the local implementationof new global QA eSystems.

  • Support transfers of new eSystems to CelgeneInternational II Sàrl and/or Celgene International Sàrl

  • Supports the Manager, QA eSystems, and the QACompliance groups with investigations, root cause analyses and CAPA definitionas needed and appropriate

Qualifications

  • At least 3 years of experience in Quality Control,Quality Assurance and/or IT in a pharmaceutical company or other relatedindustry.

  • BSc/BA (or equivalent) in Life Sciences or arelated discipline.

  • Thorough understanding of cGMPs and Swiss, EU, and FDAregulatory requirements.

  • Solid understanding of solid oral dosage formmanufacturing/packaging and QC processes.

  • Works independently, yet effectively in a teamenvironment.

  • Excellent investigational skills and QA problemsolving skills, has a keen eye for Quality.

  • Excellentwritten & oral communication skills in both English and French.

  • Goodinterpersonal and training skills.

  • Ability tofocus and an attention to details.

  • Knowledge of most common office software (MicrosoftOffice etc).

Specialist, QA eSystems

Location: BOUDRY, NE, CH

Job ID: 17001269