Principal Duties and Responsibilities:
Review departmental training requirements and ensure they are in-line with requirements.
Assure a safe and compliant work place by adhering to all EH&S procedures and reporting any health and safety issues as required.
Comply with all training requirements as required by the job function.
Liaise with other departments & ensure supporting data generated and provided in a timely manner.
Optimize reportee headcount resources and recruitment at all times. Ensure a suitably organized and managed compliance team is in place in line with the associated responsibilities.
Investigating ways to reduce waste and increase efficiency for the Compliance and Quality systems.
Responsible for Core Compliance Processes including Non-Conformance, CAPA, Audit and Risk Management Processes, Deviations.
Ensure an appropriate program is in place for GMP/GDP Regulatory Intelligence including the
monitoring and assessment of Regulatory updates and monograph revisions.
Ensure all operations are fully compliant with internal procedures, policies, license details and arrangements made to update in accordance with relevant guidelines and directives.
Responsibility for Validation planning, protocol and report review for all CMO activities.
Responsibility for setting and reporting of CMO and Group Quality KPl's (QRG).
Participate and Coordinate as required Calls with CMO’s.
Coordinate and manage the Quality Review Group for CMO and Distribution activities.
Manage and coordinate 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.
Responsibility for management of internal/external customers and competent authority audits relating to GMP, GDP and Market Compliance Activity.
Manage Internal Audit Program across Shared Service Organization GDP, CMO and HOL.
Manage and Coordinate Corporate Audit Program for Core Businesses to include Dist UK, Dist IE, Mfr and HOL Mfr.
Support CMO Business Development program tracking associated activities and actions across Reg and Quality Organization for CMO activities.
Manage and Support the KAG 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.
Manage monitoring of API CEP revisions and determine validation requirement for new versions for products that are QP released by the CMO (EU manufactured).
Ensure an appropriate program is in place to manage CMO Product Quality Reviews (PQRs) and that these are consistently completed fully and on-time. Where KAG are QP Certifying the PQR, the PQR will be completed by Quality Operations CMO team.
Coordinate and execute the ongoing Compliance Review Program.
Review and approval of CMO Master Batch Records (Batch Manufacturing & Packing records,
Review 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.
Track and investigate Compliance Department and any assigned CMO Non-Conformances and complete CAPA actions to agreed time frames.
Manage and co-ordinate Third Party Provider and CMO audit program for KAG to include 3PL’s, API Suppliers and Test Laboratories.
Manage Risk Assessment Program.
Manage KAG Data Integrity Program.
Manage the investigation of potential falsified medicines alerts for POM serialized products.
Qualifications & experience:
A minimum of 5 years’ experience at Quality Management level.
Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
Strong leadership/team management skills and experience.
Ability to prioritise, demonstrating good time management skills.
Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.