Qualified Person – Quality Assurance
Kindeva Drug Delivery formerly 3M Drug Delivery Systems, Kindeva (pronounced Kin-dev-uh) is fuelled by the same industry experts and offers the same capabilities and technologies, now with unprecedented dedication and flexibility. Our Loughborough site manufactures and packages pharmaceutical and medical products in various forms.
Job Summary
Role reporting into the Quality Assurance Manager and representing Quality Assurance and Qualified Person (QP) duties in the Manufacturing Area (Value Stream). The role will involve batch certification and day to day value stream Quality Assurance support. Site support will also be provided for the Quality Systems and continuous improvement projects related to compliance and training initiatives.
QPs are responsible for undertaking their duties in accordance with a professional Code of Practice. The aims and objectives of the Code of Practice are to provide operational guidelines for carrying out the functions of the QP in accordance with Article 51 of Council Directive 2001/83/EC and Article 12 of Council Directive 2001/20/EC for IMP QP activities.
Major Duties and Responsibilities
- Completes the duties of a Qualified Person on site for commercial products (pMDIs) in accordance with the details of the Manufacturing Authorisation and Directive 2001/83/EC
- Completes the duties of a Qualified Person on site for Investigational Medicinal Products in accordance with the details of the IMP Manufacturing Authorisation and Directive 2001/20/EC
- Attends and contributes to the site critical systems review meeting
- Reviews and provides input on compliance at the site quality assurance review meeting ensuring systems are in compliance and any actions are documented and progressed accordingly. (Review of Qualification status of relevant equipment and utilities e.g. HVAC, water etc)
- Actively involved in the Quality Systems Management Review (QSMR) meetings participating in discussions on reviewed information and providing guidance on direction and compliance
- Completes review of data at Product Quality Review meetings, ensures compliance, approval of documentation and reports. Supports any associated actions with guidance from a Qualified Person and Quality Assurance prospective.
- Works directly with Regulatory to ensure compliance with current regulations
- Completes internal and supplier audits as per agreed schedule
- Approval of deviations, quality incident and stability reports
- Drives teamwork and completes Continuous Professional Development to ensure compliance with Qualified Person duties
- Champions active visible leadership for Quality Assurance in order to promote open communication and engagement from the site.
- Creates a can-do attitude through inspirational coaching and leadership development.
- Ensure employees uphold Kindeva people policies and ethical behaviours / Kindeva values related to compliance and quality systems
- Support learning, development and coaching in the value stream relating to compliance and GMP training
Qualifications
- Eligible to act as a QP (Commercial product essential, IMP preferable)
- Recently Qualified or experienced QP
- 3+ years working in the Pharmaceutical Industry
Click here to apply
Please apply asap, if you have any questions email Rebecca.Ellis@Kindevadd.com