Qualified person

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in revolutionising modern addiction treatment.

Indivior is dedicated to transforming addiction from a global human crisis to a recognised and treated chronic disease. Indivior radiates its patient-oriented, holistic focus on expanding access to quality treatment for addiction worldwide. We have a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.

POSITION SUMMARY:

We are looking for a QP to perform Commercial supply chain oversight and QP certification, on behalf of Indivior Europe, of contract manufactured products where Indivior Europe is the named importer and batch release site within Marketing Authorisations held within the (European Economic Area) EEA. In support of Qualified Person Certification activities, maintain and develop the Quality System that supports batch certification and release operations within Indivior Europe ensuring maintenance of GMP requirements for batch release and the conditions of the Manufacturers Import Authorisation (MIA).

ESSENTIAL FUNCTIONS:

Supply Chain and Contractor relationships and product familiarisation

1. Establish effective working relationships with INDVs primary Contract Manufacturing Organizations (CMOs), Contract Packaging Organizations (CPOs) and contract laboratories that form part of the commercial pharmaceutical supply chain.
2. Develop a clear knowledge and understanding of the facilities, manufacturing and operational processes and activities of CMOs, CPOs, and laboratory testing sites that form part of the commercial pharmaceutical supply chain.
3. Contribute to and deliver GMP and GDP compliance audits, supporting the global external vendor management program
4. Familiarisation with product, process and equipment validation relating to the commercial product portfolio.
5. Familiarisation of CMO, CPO and contact laboratory Site Master Files and competent authority inspection history.
6. Directly support and lead when necessary Quality review meetings with CMOs, CPOs and contract laboratories, including the development and review of Keep Performance Indicators. As necessary support CMOs, CPOs and contract Laboratories with Continuous Improvement initiatives and projects for process improvement.
7. Provide real time input to deviations and changes communicated from CMOs, CPOs and contract laboratories relating to product manufacture, packaging and testing.
8. Contribute to factory and Governance meetings with CMOs, CPOs and Contract laboratories.
9. Contribute to the compilation and maintenance of Commercial product supply chain maps

Batch certification and release product

1. Develop  expertise of product Marketing Authorisations within the EEA to allow certification of products in compliance with registered dossiers.
2. Review and assess completed batch manufacturing and packaging records, analytical results and analytical methodology and local (site) GMP certification documentation. Ensure requirements for product serialisation are met and reconciliation performed, including the uploading of serialisation data to the EMVO.
3. Review and assess details of deviations, associated investigations, root cause analysis and CAPAs relating to a specific batch or series of batches of product and consider impact on product quality, efficacy, safety and compliance with the MA.
4. Review and assess Change controls relating to a specific batch or series of Batches of product, and consider impact on product quality, efficacy, safety and compliance with the MA.
5. Maintain a register of product certifications and create Certificates of Conformance (CoC) for all batches certified and released to market. Maintain documentation packages that support certification and release decisions.

Quality Management System

1. Maintain a working knowledge of the Indivior global and local quality system elements and contribute to their maintenance and continuous improvement.
2. Ensure the compilation and appropriate dissemination of PQRs in a timely manner.
3. Ensure the timely completion and review of Ongoing Stability programs for commercial products.
4. Provide input into the review, approval and response to Product Quality Complaints.
5. Support delivery of local and global Internal Audit programs.
6. Contribute to and lead, as necessary, GxP Critical Events such as recall activities for commercial products.
7. Support the delivery of the GMDP Vendor Assurance program for the commercial supply chain
8. Ensure Quality Technical Agreements (QTA) are in place and contribute to their implementation and update where necessary.
9. Support the raising of deviations and change controls within the in Indivior Quality system to mirror CMO / CPO issues, or independently, where issues of internally identified.
10. Ensure communication of and agreement with Indivior Europe QPPV where deviations potentially impact patient safety as the releasing GMP QP.
11. Ensure issues resulting in GxP Critical Events are managed and communicated in accordance with procedure and in a timely manner.

Licence Responsibilities

1. 1. 1. 1. Awareness of processes in -place for MIA maintenance.
         2. Maintain Qualified Persons status. Ensure personal capability and credentials to act as a QP and meet all CPD requirements.
         3. Ensure personal knowledge is maintained in EU and EEA territory cGxP principles to allow batch certification and release.
         4. Support Competent Authority (HPRA) site inspections against MIA for GMP compliance.
         5. Assist in providing regulatory oversight and reporting on the INDV Narcotic License where named in EU and EEA countries.

MINIMUM QUALIFICATIONS:

• At least five (5) years experience working in a Healthcare or Pharmaceutical related industry.
• Working knowledge of EU and FDA Medicines legislation and good practices. Knowledge of Wholesaling legislation in Eu and EEA countries eg EU 2013/C 343/01, EU 2015/C 95/01.
• Working knowledge of EU and EEA and Narcotic legislation and controls.

License/Certifications:  - Current QP certification status is essential for MIA operations of Indivior Europe.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

• Thorough understanding of regulatory requirements relevant to Indivior.
• Strong auditing skills/qualifications with a comprehensive understanding of key pharmaceutical processes, validation, facility and service requirements.
• Detailed understanding of cCGxP requirements relevant to Indivior products (e.g. GMP, GDP, GPvP.)
• Proven track record in Healthcare or Pharmaceutical quality management systems.

Indivior is committed to providing a foundation for each employee’s success and growth. We are an equal opportunities employer and welcome applications from all.