QA Compliance Specialist

Employer
Marketplace Technical
Location
Borehamwood, UK
Salary
Competitive
Closing date
6 Oct 2020

View more

Sector
Healthcare
Contract Type
Permanent
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International Pharmaceutical Manufacturer requires a QA Compliance Specialist.

About the role:
  • Influence and support GxP compliance in all activities performed on site by developing, implementing, maintaining and continuously improving quality standards and systems to ensure that all applicable company operations and processes conform to the principles of GxP
  • Lead Annual Product Reviews, Drive Good Distribution Practices, Develop and maintain the Change Management process, Generate / update Certificate of Analysis and customer documents in line with required regulations.
  • Analyse/trend data, assess information and generate reports/metrics in order to provide accurate and appropriate responses and to identify potential risks and gaps.
  • Provide support to Continuous Improvement Projects where appropriate

Duties may include:
  • Build and maintain strong relationships with key business stakeholders and ensure that each department is adhering to the GMP compliance and regulations
  • Manage and provide site wide GMP, GDP and Change Control training
  • Drive Annual Product Review (APR) Execution
  • Coordinate the collation of Annual Product Reviews and Summary Reports
  • Management of the current APR process to meet regulatory requirements
  • Lead GDP Excursion Monitoring and Rectification
  • Review temperature data for product shipments
  • Monitor GDP excursions and implement appropriate remediation
  • Raise, Investigate, review and Close GDP Incidents
  • Host GDP Meetings internally and with Freight Forwarders to rectify identified GDP issues
  • Ensure valid Route Risk Assessment approved prior to shipping
  • Drive Change Control Management across site
  • Coordinate and review Change Control records for accuracy and completion
  • Enforce zero overdue Change Control records
  • Maintenance and oversight of the TrackWise system to drive closure of overdue/extended records
  • Prepare and present metrics (e.g. complaint metrics, change control metrics etc.) to Quality Management on a monthly basis (e.g. Quality Council) or upon QA Management's request
  • Collate, review and interpret data from the QMS to support the action and closure of non-compliance issues, thereby supporting continuous improvement of the QMS
  • Coordinate the review and approval of Specifications by internal and external units as applicable
  • To provide QA documentation required for the shipment of product to Export Markets including Certificate of Analysis, Batch Protocols and Plasma Quality Certificates
  • To maintain/develop all necessary documentation and systems to ensure effective implementation and monitoring of quality standards in accordance with GMP
  • Participate/observe Internal Audits to proactively identify compliance issues
  • Participate/Support in the regulatory inspection (front room / backroom)
  • Carry out in progress or post inspections of completed compliance works to ensure adherence to regulatory and statutory requirements
  • Self-Inspection and Lot Distribution schedule adherence
  • Support delivery of site and departmental objectives
  • Participate and contribute to the development of the department
  • Maintain and continuously improve the QMS
  • Ensure effective communication within the organisation and the Quality Group
  • Support manufacturing and other operations in the development, implementation and maintenance of GxP standards
  • To provide training on relevant Quality Systems when required
  • Work closely with all teams especially Commercial to ensure Customer Satisfaction

Skills and experience:
  • A degree in Life Sciences or equivalent
  • Knowledge and understanding of Quality Assurance, GxP requirements and Quality Management Systems preferably from a Pharmaceutical Industry
  • A strong background in compliance monitoring
  • A high level of written English and oral communication skills, including a proven ability to produce high quality written reports, present information in the most appropriate format and ensure accuracy of technical content
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