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QA Compliance Manager

  • Team Horizon
  • Roscommon

To apply for this job email your details to ashling.guthrie@teamhorizon.ie

Team Horizon currently has an exciting opening for a QA Compliance Manager to work on our client’s manufacturing facility in the midlands.

Why you should apply:

  • The company manufacturers and distributers for speciality off-patent/generic pharmaceuticals across the UK, Ireland and international markets
  • Their portfolio of products is diversified across multiple therapeutic areas, with particular strengths in analgesics and anti-infectives.
  • Mainly niche, value-added products, which are complex to manufacture.
  • With a strong pipeline of new product development, the company continues to grow in each of their key areas

What you will be doing:

  • Reviewing departmental training requirements to ensure optimisation.
  • Assuring a safe and compliant work place by adhering to all EH&S procedures
  • Complying with all training requirements as required by the job function.
  • Liaising with other departments, ensuring supporting data generated and provided in a timely manner
  • Optimising headcount resources and recruitment at all times.
  • Ensuring an organized and managed compliance team is in place
  • Investigating ways to reduce waste and increase efficiency for the compliance and Quality systems
  • Looking after core compliance processes including non-conformance, CAPA, audit and risk management processes, deviations.
  • Ensuring an appropriate program is in place for GMP/GDP Regulatory Intelligence including the monitoring and assessment of Regulatory updates and monograph revisions.
  • Ensuring all operations are fully compliant with internal procedures, policies, license details and arrangements made to update in accordance with relevant guidelines and directives.
  • Validation planning, protocol and report review for all CMO activities
  • Setting and reporting of CMO and group quality KPIs (QRG)
  • Participating and coordinate as required calls with CMO’s
  • Coordinate and manage the review group for CMO and distribution activities
  • Managing and coordinating Technical Agreement (TA’s) compliance across shared service organization
  • Taking ownership and control of TA’s relating to CMO activities
  • Maintenance of the stability master plan and stability activities carried out at all Third Party CMOs.
  • Managing internal/external customers and competent authority audits relating to GMP, GDP and Market Compliance Activity.
  • Managing internal audit program across shared service organization GDP, CMO and HOL
  • Managing the coordinate corporate audit program for core businesses
  • Supporting CMO Business Development program tracking associated activities and actions across Reg and Quality Organization for CMO activities.
  • Managing and supporting the contract manufacturing compliance process to ensure all third-party Manufacturers, packing sites and test laboratories are assessed for compliance to GMP and the appropriate market authorisations in line with responsibility matrix.
  • Responsibility for managing CMO changes through Change Control Process in line with Responsibility Matrix
  • Provide Non-Conformance Investigation training and maintaining in an up-to-date state.
  • Ensure compliance with Quality KPI’s and timelines across Shared Service (GDP, CMO and HOL) through processes such as open actions meeting, quality review group and audit steering committee.
  • Managing monitoring of API CEP revisions and determine validation requirement for new versions for products that are QP released by the CMO (EU manufactured)
  • Ensuring an appropriate program is in place to manage CMO Product Quality Reviews (PQRs) and that these are consistently completed fully and on-time.
  • Coordinate and execute ongoing Compliance Review Program,
    Reviewing and approval of CMO Master Batch Records (Batch Manufacturing & Packing records, Validation/Stability Protocols and Report, Finished Product Specifications and End of Shelf-Life specifications) in line with Responsibility Matrix.
  • Tracking and investigate compliance department and any assigned CMO Non-Conformances and complete CAPA actions to agreed timeframes
  • Manage and co-ordinate third party provider and CMO audit program to include 3PL’s, API Suppliers and Test Laboratories.
  • Delivering the risk assessment program
  • Overseeing the data integrity program
  • Managing the investigation of potential falsified medicines alerts for POM serialized products

What you need to apply:

  • Bachelors of Scientific degree, ideally in pharmacy, pharmaceutical sciences, chemistry
  • A minimum of 5 years’ experience at Quality Management level.
  • Good leadership/team management skills and experience.
  • Ability to prioritise, demonstrating good time management skills.
  • Brilliant attention to detail
  • The ability to work accurately in a busy and demanding environment.

To apply for this job email your details to ashling.guthrie@teamhorizon.ie