QA Compliance Manager

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.