Quality Specialist- FCP
About the role
The Quality Specialist, FCP is embedded in the Quality Assurance team reporting to the Head of QA and QC. This role supports management, maintenance, and continuous improvement of the quality system at the Indivior Fine Chemical Plant (FCP).
Responsibilities
Manage and maintain the QMS to assure document control activities, deviations, CAPA, change control, complaints, OOS/OOT and APQRs are completed in an effective and timely manner to support consistent compliance to KPI targets, GxP requirements and Indivior policies and procedures.
Act as eQMS superuser, support administration and use of the system through technical support and training.
Manage and report site Quality KPIs and metrics escalating trends and risks to senior Quality, Supply, Global and FCP leadership as required.
Identify and implement initiatives to support continuous improvement of quality and compliance standards across operations at FCP.
Organise and manage the site monthly Quality meetings providing a status review of the FCP QMS to FCP Leadership, with responsibility for agendas, meeting minutes and tracking of agreed actions.
Support and participate in quarterly Quality Management Review meetings ensuring trends, risks and actions points are documented and communicated to senior Quality, Supply, Global and FCP leadership as required.
Support regulatory authority inspections and customer audits by maintaining a state of inspection readiness, hosting audits and supporting follow-up of any post inspection/audit responses, commitments and actions.
Draft and submit interim compliance reports to be provided to MHRA when required (pre audit, major change) under the direction of the Head of QA and QC, VP of Global Quality or delegate.
Generate quality scorecard and attend monthly meeting.
Manage the FCP self-inspection program through scheduling, performing and closing internal audits through partnership with internal and external functions.
Act As deputy for the Head QA & QC where authorised. For example: Support 3rd party API suppliers to prevent delays to manufacture.
Present at various forums as required e.g. Monthly FCP Leadership Quality Scorecard review.
Any other duties required in the absence of the Head of QA & QC, FCP.
Supplier and Customer Management (Audits and Technical Agreements)
Onboard FCP suppliers and service providers in accordance with Indivior policies and procedures.
Maintain the FCP Approved Suppliers lists.
Implement and maintain Technical Agreements with suppliers and service providers, where required.
Manage the FCP supplier audit schedule.
Work with FCP suppliers and Procurement to schedule audits in compliance with the approved audit schedule.
Perform supplier audits, support Global Audit team as an API manufacture SME.
Manage and support close out of CAPA plans where required following audits.
Manage the system for the continued review / reporting for supplier status and alert reporting through direct communication with the service providers and resolve issues before escalation.
Good Distribution Practice
Ensure that all GDP requirements are met according to Indivior policies and procedures and applicable GxP requirements.
Perform Bona Fide checks on suppliers and customers in accordance with Indivior policies and procedures.
Batch Record Review and Release
Review and approve production batch records for intermediates and finished product to assure manufacturing schedules are maintained and supported.
Support internal partners with training on correct completion of batch records and associated quality records to continuously improve quality standards and compliance.
Generate and approve CoAs.
Implementation and ongoing management of contracted microbiological testing.
Training
Generate and maintain training matrix for GMP impacting processes and procedures, support creation and maintenance of role specific curricula in the LMS.
Act as LMS superuser for the FCP support administration and use of the system through technical support and training.
Assess Indivior global SOPs to assure FCP policies and procedures are aligned.
Monitor completion of training items escalating any overdue items to the FCPLT.
Stability
Manage the implementation and ongoing management of stability programs for API’s manufactured at the FCP including generation and approval of protocols and data tables, coordination of timepoint sample analyses, review and approval of reports both internally and at third parties.
Validation and Qualification
Manage the validation and qualification process (including cleaning) at FCP, ensuring producers and templates are maintained in the eDMS.
Act as quality approver for validation documents.
Ensure completed validation documents are stored in the eDMS.
Implement and manage a continuous verification process for the manufacture of APIs.
Qualifications
Education: Bachelor of Science degree is preferred but not essential. MINIMUM Field of Study: Chemistry, Biology, Pharmacy or similar.
Experience: Minimum of 5 years in a GxP environment, ideally but not necessarily in the API manufacturing area.
Travel: International and domestic travel will be required for audit, meetings, conferences etc.
Competencies/Conduct
Highly motivated and flexible approach to results delivery.
Solid competencies to manage multiple tasks and priorities within a fast-paced, entrepreneurial environment.
Excellent communication skills - presentation, written and oral.
Proven ability to work under pressure without compromising deliverables.
Strong GxP knowledge predominantly in GMP environments.
Strong computer skills including Microsoft platform.
Knowledge of Veeva eQMS an advantage.
Knowledge and experience of working with controlled drugs.