Quality Operations/Compliance Manager
Quality Operations/Compliance Manager & QP. Key Purpose: ICDS are looking to recruit a Quality Operations/Compliance Manager for a large Pharmaceutical company. The ideal Candidate will be responsible for Site and CMO activities, , Quality Assurance / Compliance Officers, QA and Compliance Administrators and will work collaboratively with Regulatory, PV, Artwork Group, Supply Chain, Commercial, Contract Manufacturing Organisations (CMO’s). The role will report to the Director of Regulatory and Quality Operations. Key Responsibilities: Responsibility for maintaining and improving the Quality Management Systems supporting the CMO activity and ensuring that all aspects of the Quality Management Systems are up to date with Current GMP requirements. Support the release and testing of batches manufactured by 3rd country CMO’s. Manage and oversee Non-Conformances and Deviations associated with the manufacture of product. Manage and oversee the assembly, review and release of CMO batches released under any subsidiaries. On completion of review of compliance with GMP and current MA, QP Release Own site and CMO Batches as Assigned. Manage and oversee Planning, Non-Conformances and Deviations associated with the manufacture of batches Overlabelled in the UK Facility and associated QP Release. Ensure all operations are fully compliant with internal procedures, policies, license details and are updated in accordance with relevant guidelines and directives. Responsibility for the Organisation, motivation, development and performance management of Quality staff (Quality Assurance / Compliance Officer / Compliance Administrators. Optimize reportee headcount resources and recruitment at all times. Ensure suitably organized and managed QA and compliance team is in place in line with the associated responsibilities. investigating ways to reduce waste and increase efficiency for the Quality systems. Responsibility for setting and reporting of Quality KPl's (QTM/QRG. Support all operational and agreed project targets as agreed with management team. Support the Approval Validation templates and work instructions. Responsibility for validation related documents generated internally and manage process for review of validations. Liaise with other departments to progress specific validation projects in a timely manner. Planning of validation as per the Validation Master Plan. Maintenance of the Stability Master Plan and stability activities carried out at Third Party CMOs. Responsibility for management of internal/external customers and competent authority audits relating to CMO and Market Compliance Activity. Manage the tracking and completion of Active Pharmaceutical ingredient (API) manufacturing site audits as well as review of reports. Manage and Support as required all Pharmaceutical 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. Responsibility for maintaining and improving the vendor approval process. Responsibility for achievement of site objectives. Review departmental training requirements and ensure they are in-line with training policy. Provide GxP training and maintaining in an up to date state. Responsibility for Procedure / Software/Equipment/process change review and approval. Develop and maintain familiarity with applicable legislation, guidelines and current industry practice that impact the QMS and validation activities. Ensure an appropriate program is in place for GMP/GDP Regulatory Intelligence including the monitoring and assessment of Eudralex updates and monograph revisions. Manage monitoring of API CEP revisions and determine validation requirement for new versions Provide management oversight and ownership of the system used to initiate, track and investigate non-conformances and PIRs to Good Manufacturing Practice (GMP) and Market authorisation. Ensure an appropriate program is in place to manage Product Quality Reports (PQRs) and that these are consistently completed fully and on-time. Manage the review and approval of Master Batch Records (Batch Manufacturing & Packing records, Validation/Stability Protocols and Report, Finished Product Specifications and End of Shelf Life specifications. Assure a safe and compliant work place by adhering to all EH&S procedures and reporting any health and safety issues as required. Track and investigate any assigned investigations and complete CAPA actions to agreed timeframes. 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. Qualifications & Experience: A minimum of 7 years’ experience at Quality Management level. Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related) and QP Qualified. 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.
159 days ago