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Senior Manager QA Ireland-Nordics Compounding

Req #: 18000045_en
Location: Dublin, L IE
Job Category: Quality
Date Posted: 3/23/2018 6:38:54 AM
Baxter International

Description

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre 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.
 
 
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
 
The Role
As a Senior QA Manager (Ireland, Nordics) you will be responsible for leading Quality Assurance in Ireland & Nordics compounding units.  You will ensure that the appropriate risk identification and management process are implemented.
 
Responsibilities
  • Set objectives for local QA manager and QA representatives.
  • Ensure that local QA teams provide oversight of calibration, validation and maintenance programs at site level.
  • Document and data management.
  • Ensure the implementation and management of the Baxter quality system within the compounding units.
  • Ensure that units are compliant with the manufacturing license, customer requirements and Baxter requirements.
  • Act as point of contact of compounding with local regulatory agencies with regards to GMP.
  • Oversee the site audit readiness program and manage the audit process for the facilities.
  • Ensure that audit findings are fully investigated to find root cause and that actions are taken to address the issue.
  • Ensure the presence of a compliant and effective release process; ensure that product meets specification and customer order prior to release, and is release on schedule.
  • Work closely with manufacturing staff to ensure units meet customer expectations on delivery time and product quality.
  • Ensure that appropriate sterility assurance level is applied and reached by processes.
  • Ensure that each site implement and update yearly, a continuous training program focused on microbiology and aseptic techniques.
  • Ensure that all complaints reported by customers are appropriately documented and investigated as required.
  • Accountability for; reporting any complaints that may result in Field Corrective Action, reporting any adverse events to Pharmacovigilance, all complaints investigation content meets GMP regulation and corporate standards.

Qualifications

  • Masters in Science.
  • Strong relevant experience in QA for the Pharma/Healthcare Industry, especially in regards to sterile aseptic products.
  • Experience with audit preparation, hosting and follow-up.
  • Front-end exposure to HPRA, MHRA inspections, and communications.
  • Knowledge of isolator technology and environmental/microbiological control.
  • Validation.
  • Team/People management.
  • Ability to communicate in a clear and concise manner.
 
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.
 
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