TITLE:
Quality Specialist- FCP
Title: Quality Specialist, FCP
Reports To: Head of QA & QC, FCP
Location: Hull, FCP
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of OUD. Indivior is dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
POSITION SUMMARY:
Embedded in the Quality Assurance team reporting to the Head of QA and QC, this position is a hands-on role tasked with supporting management, maintenance and continuous improvement of the quality system at the Indivior Fine Chemical Plant (FCP). This role has responsibilities in assuring FCP operations are in compliance with Indivior Global Quality Policies, applicable GxP requirements and the organisation’s expectations with respect to Quality owned KPIs and metrics. This position will also have responsibility for the FCP vendor assurance programme undertaking activities required to have effective vendor oversight and governance. This position will act as a business partner to both internal and external stakeholders. Responsibilities include, but are not limited to, management and execution of batch review to assure timely release of API, the generation, execution, reporting and review of GxP quality records, reporting and escalation of potential issues and compliance risks and execution of internal and vendor auditing. This position will own management of stability programmes performed both internally and through third parties as applies to Indiviors API’s. This role will act as eDMS Document Controller and eQMS Super user. This role will require participation in various quality and operational forums where SME input is required and as directed by the Head of QA and QC or the business. The role will involve supervision of direct reports assigned as per business needs with accountability to drive performance, competencies and personal development. Where authorised to do so this individual may be required to assume some of the responsibilities of the Head of QA and QC as a deputy from time to time.
Any available time not required to execute these responsibilities is to be utilized at the discretion of the VP, Global Quality or delegate.
ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:
Quality Management
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:
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Support 3rd party API suppliers to prevent delays to manufacture.
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Present at various forums as required e.g. Monthly FCP Leadership Quality Scorecard review
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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. Generation and approval of 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.
Manage On-going Stability of API’s manufactured at the FCP including generation and approval of protocols and data tables, co-ordination of timepoint sample analyses, review and approval of report 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.
MINIMUM QUALIFICATIONS:
Education: Batchelor of Science degree is preferred but not essential
MMINIMUM
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:
In addition to the minimum qualifications, the employee will demonstrate:
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Highly motivated and flexible approach to results delivery
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Solid competencies to manage multiple tasks and priorities within a fast-paced, entrepreneurial environment.
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Excellent communication skills - presentation, written and oral.
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Proven ability to work under pressure without compromising deliverables.
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Strong GxP knowledge predominantly in GMP environments
- Strong computer skills including Microsoft platform. Knowledge of Veeva eQMS an advantage.
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Knowledge and experience of working with controlled drugs
PREFERRED QUALIFICATIONS:
Pharmaceutical/ISO Auditing Course
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled
