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Quality Control Systems Specialist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location:
  • Sector: Quality & Compliance
  • Date posted: 20/09/2018
  • Job reference: BBBH88211

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Quality Control Systems Specialist

My client is offering a new opportunity for a Quality Control Systems Specialist to join the quality team.

The QC Systems Specialist role will provide in-line technical support in relation to Laboratory Systems such as LIMS, Empower, SAP, instrument software and Data Integrity to ensure the quality pharmaceutical products meeting the priorities of: Compliance, Supply, Strategy and Profit Plan.

The Laboratory Systems Specialist role acts as LIMS Site Administrator, Empower Administrator and SAP (QM) master data maintainer for the site Laboratories and is required to be a subject matter expert in these areas. The role supports all internal customers including QC, QA, Automation and Operations. The role also supports external customers when required such as other organisational sites and Global functions. A high level of self-motivation, knowledge, enthusiasm and drive is required.

Responsibilities:

  • Provide efficient support to all departments including QC Microbiology, Quality Control and IPT for issues pertaining to LIMS, Empower and SAP.
  • Deliver systems training to new hires and existing personnel.
  • Development and testing of systems and perform new master data builds for the introduction of new products.
  • Provide technical support and liaise with Global systems working groups.
  • Provide subject matter expertise in relation to Laboratory Systems. Works on improvement projects in relation to LIMS and other laboratory systems as required.
  • Actively identifies and progresses continuous improvements. Ensures strict adherence to site policies/procedures and GMP.
  • Coach existing personnel onsite on the use of Laboratory Systems.
  • Leadership activities including selection, development, coaching and day to day management and developing and maintain training programmes.
  • Required to comply with my clients Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices.
  • Performs assessments and overview of systems from a data integrity perspective.
  • May be required to perform other duties as assigned.

Qualifications:

  • Bachelors Degree or higher preferred; ideally in Science/IT or a closely related discipline
  • Considerable experience and critical skills in Laboratory Systems setting. LIMS, Empower and SAP.
  • Change Management Skills (CEM) with continuous improvements.
  • Knowledge of cGMP and GDP preferred
  • Lean Six Sigma Methodology experience desired

Initial Travel Requirements:

  • Occasional travel may be required.
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