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Senior QA Associate

Req # JR - 023576 Location Oxford, England, United Kingdom Additional Locations 37.5 Job Category Quality Control Date posted 07/09/2020

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Summary

We are currently looking for a Senior QA Associate to work from our high performing site in Oxford. The role is intended to support the maintenance, performance and improvement of the Quality Management Systems as well as support the release of ‘’specials’’ products manufactured at the Oxford Compounding site. The Senior QA Associate will report to the QA Manager ensuring continuous compliance of the Compounding unit to cGMP and ‘’specials’’ manufacturing requirements, local procedural requirements and Baxter Corporate Policies. The shifts will be working between 07:00-15:00, 10:00-18:00, Monday to Friday on a week by week rotation.

Role Responsibilities

Change Control

  • Support maintenance of effective change control process to ensure all changes are fully documented and impact of change evaluated across the site
  • Generate and maintain Change Control impact assessment tools and workflows to ensure all impacted products, processes, procedures, stakeholders and sites are evaluated and approved by applicable functions, prior to initiating a change.
  • Track and monitor the progress of initiated Change Controls to ensure timely completion.
  • Ensure all change control deliverables are completed prior to closure of a Change

Validation

  • Management of the site Validation Master Plan
  • Ensuring all equipment used for the manufacture and storage of product is validated before use
  • Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan.

GMP and Facilities and Equipment Control

  • Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct.
  • Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete.
  • Investigation of out of limits results using exception and CAPA processes.

Quality System Measurement and Review

  • Identify, track, trend and report Key Performance Indicators (KPIs) for processes under role responsibility to identify opportunities for improvement
  • Support Quality Management Reviews through trending and reporting of applicable Quality Management System data.
  • Ensure outcomes, decisions and actions of the review are documented and support timely completion of actions arising from QMR

Complaints

  • Ensures all incidents reported by customers are appropriately documented and investigated
  • Support update and maintenance of local Complaints procedures and processes in line with Corporate, Compounding and Regulatory requirements.
  • Reporting any adverse events to Pharmacovigilance and the Business management representative

Exceptions

  • Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated
  • Review and approval of exception reports
  • Leading and coordinating investigations in the cause of exceptions

Corrective and Preventative Action

  • Management of the CAPA system using TrackWise software
  • Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames
  • Raising supplier corrective actions to address out of specification raw material issues
  • Management of Supplier Corrective Action using TrackWise software

Audit Management

  • Support Internal, Corporate, external Regulatory and Customer audits through provision of requested documentation, records and information in a timely manner.
  • Ensures that the facility is always ready for an internal, corporate, MHRA or 3rd party audit
  • Manages the audit process for the facility, organization of the management team and staff to ensure a successful audit
  • Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue

Post Compounding check and Release

  • Responsible for the Review of prescriptions on Merlin
  • Responsible for release activities associated with products manufactured at the compounding units

Communication and Training

  • Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance
  • Ensures staff understand their responsibilities under the quality system regulations=
  • Communicates changes of the quality system to staff, ensuring appropriate training programs are executed.

Document and Data Management

  • Ensures all procedures are controlled and current versions are available to staff as required
  • Ensures there are no unauthorized changes to documents including creation of local documentation.
  • Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
  • Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible

Qualifications & Experience

  • Degree level or equivalent in Pharmaceutical, Biotechnology, Chemistry, Microbiology or Engineering degree.
  • Extensive experience in Pharmaceutical, Medical Device, Biotechnology, Chemistry, Microbiology or other related regulated industry.
  • Proven knowledge of Quality System processes (essential), with working knowledge of current EU and UK GMP requirements (EU GMP Annex 1) (preferred), or experience of working within ISO 9001, ISO 13485, MDD 93/42/EEC, or similar regulations and standards (considered).
  • Experience of supporting regulatory inspections.
  • Experience of coordinating and supporting Document Control, Internal Audit, CAPA, Non-conformance and Complaints processes (required).
  • Experience of problem solving using Root Cause Analysis techniques such as 8D, GEMBA, 5 Whys, Cause and Effect (required).
  • Internal and external audit experience (desired).
  • Working knowledge and hands on experience of software tools to manage Quality Systems processes such as TrackWise, Agile, MasterControl, QPulse (beneficial).

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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