Overview

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Facility Compliance:

Liaise with vendors for critical & non-critical maintenance. Plan annual calendar for calibrations, certifications, maintenance and cleaning, PVs.

  • Collaborate with QA team for changes to corporate or regulatory standards that impact on facility maintenance and calibration/certifications
  • Notify contractors of any changes to standards or procedures
  • Ensure new contractors receive site orientation and training, as appropriate
  • Update Preventative Maintenance task list as appropriate, and activities completed to schedule
  • Source vendors for facility maintenance as required and engage contractors per management decision
  • Review results and follow up / investigate OOS results
  • Support ISO Train system updates as necessary
  • Manage the GMP Calendar

NCRs and CAPA, Audits:

Perform quality related investigations with QA and site operations team, and provide information for responses to quality issues (NCRs, CAPA, Complaints, Audits etc.)

  • Work with the Operations and QA teams to ensure readiness of the site for any internal or external inspections / audits
  • Preparation of responses to QA investigations (CAPA, complaints, non-conformances) and audit processes as required
  • Use Human Factors toolkit to identify root causes of human failure and effect corrective actions accordingly.
  • Apply root cause analysis of quality incidents to improve operational processes.

Qualifications:

  • Science Graduate, Pharmacist or equivalent
  • Experience in pharmaceutical compounding in either hospital or private organisation
  • Knowledge of the principles of cGMP
  • Thorough knowledge and adherence to CIVA procedures
  • Ability to build and maintain effective relationships with internal/external customers
  • Ability to prioritise tasks
  • Ability to make decisions on sound professional judgement

To apply for this job please visit the following URL: http://jobs.baxter.com/ShowJob/Id/133744/Compliance Specialist →


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