Baxter QA Associate - Stockport NWU in England, United Kingdom
Job title: QA Associate, UK Compounding - Stockport NWU Reporting to: Site Quality Assurance Manager Issue date: July 2016 Supersedes:
Business: Medication Delivery Sub business: Compounding Job Code: ZQ1300 Country: UK Location: Compounding Units
Works closely with manufacturing staff to ensure the unit meets customer expectations on delivery and product quality.
Responsible for release of product from the system.
Responsible for supporting production in the review and post compounding check operations.
Responsible for implementation and management of the Baxter quality system within the compound unit. Ensuring regulatory compliance.
Ensure that unit is compliant with all corporate quality system policies and procedures. Responsible for review of the implementation of the Baxter Quality System to initiate, and drive continuous improvement
ESSENTIAL DUTIES AND RESPONSIBILITIES
Post Compounding check and Release
o Responsible for the Review of prescriptions on Merlin
o Responsible for release activities associated with products manufactured at the compounding units.
o Maintain a local change control process to ensure all changes are fully documented
o Ensuring all changes are assessed for risk and impact prior to implementation
o Ensuring that all changes are completed fully as per impact assessment and in the appropriate time frame
o Management of the site Validation Master Plan
o Ensuring all equipment used for the manufacture and storage of product is validated before use
o 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
o 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.
o 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
o Investigation of out of limits results using exception and CAPA processes
o Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
Quality System Measurement and Review
o Ensure outcomes, decisions and actions of the review are documented
o Ensure meeting actions are completed to agreed deadlines
o Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints. Trending should include timeliness in completion as well as actual numbers
o Ensures all incidents reported by customers are appropriately documented and investigated
o Management of complaints using TW8
o Responsible for reporting any complaints that may result in Field Corrective Action immediately to the Business management representative and also the European FCA gatekeeper
o Reporting any adverse events to Pharmacovigilance and the Business management representative
o Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated
o Review and approval of exception reports
o Leading and coordinating investigations in the cause of exceptions
Corrective and Preventative Action
o Monitor all quality system processes to detect need for improvements
o Management of the CAPA system using Track wise software
o CAPA owner and leader
o Ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed according to agreed time frames
o Raising supplier corrective actions to address out of specification raw material issues
o Management of Supplier Corrective Action using Trackwise software
o Ensures that the facility is always ready for an internal, corporate, MHRA or 3rdparty audit
o Manages the audit process for the facility, organization of the management team and staff to ensure a successful audit
o 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
Communication and Training
o 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
o Ensures staff understand their responsibilities under the quality system regulations
o Communicates changes of the quality system to staff, ensuring appropriate training programs are executed.
Document and Data Management
o Ensures all procedures are controlled and current versions are available to staff as required
o Ensures there are no unauthorized changes to documents including creation of local documentation.
o Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
o Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible
Science degree e.g. Pharmacy, Chemistry, Microbiology or equivalent BTech- Pharmaceutical Science or equivalent work experience
English GCSE or equivalent
Breadth & Depth of experience 2 years experience of working in a aseptic compounding operation 12 months experience of quality system implementation Field of expertise: Ideally experience in all or any of the following: Quality system management and implementation Environmental / microbiological control
Validation Risk management
Organization: *Global Compounding Quality
Title: QA Associate - Stockport NWU
Requisition ID: 1700062U