Quality Assurance Assistant

6 months ago

London, United Kingdom CNX Therapeutics Ltd Full time

**JOB DESCRIPTION**

**Job title: Quality Assurance Assistance**

**Reporting to: Quality Assurance Manager**

**Department: Quality Assurance**

CNX Therapeutics is a European pharmaceutical company dedicated to improving the lives of patients through the supply of essential medicines. We commercialise and distribute a portfolio of speciality brands and hospital products in Europe, in 40 countries worldwide, both directly and through strategic partnerships. Our vision is to become a recognised partner of choice through our commercial excellence, patient focus and presence across Europe.

We want to be Pioneers We may be small, but we’ve got some big goals. That’s why, at CNX, ESG (Environmental, Social, and Governance) isn’t just a fancy acronym; it’s a roadmap to our future success. Why, you ask? Well, it’s because we want the work we do to have a positive impact, on ourselves, on each other, on the world we live in and on the patients we serve.
And guess what? It’s on all of us to do this. So, whether you’re crunching numbers, selling products, moving those products around, maintaining our high ethical standards, or brainstorming new ideas, remember that every small action counts. CNX will do its bit for you through our inclusive and family-friendly benefits and ways of working, supporting your professional and personal growth, so you are empowered to pay it forward every day.

**Purpose of the position**

Work with the QA department and with internal and external customers to achieve a common goal and ensure GxP activities e.g. GDP, GMP, GVP conducted by CNX are implemented and controlled.

A varied role requiring management of tasks and priorities to ensure that CNX systems and procedures comply with relevant standards, guidelines and regulations including, but not limited to, European Directive 2003/94/EC for Good Manufacturing Practice, European Union Guidance on Good Manufacturing Practice Part 1: Basic Requirements for Medicinal Products, Guidelines on Good Distribution Practice of Medicinal Products for Human) 2013/C 343/01.

**Core Duties**

Live the CNX Values. Maintain high standards of ethics and support the company in its efforts to have a pioneering approach to environmental, social and governance (ESG).
- Support the maintenance of the Quality Systems to ensure GMP/GDP/GVP compliance and promote “Quality Awareness” within CNX.
- Administrative responsibility for the eQMS, document generation, management & archiving within the system.
- Responsible for coordination of the SOP Training Matrix and allocation of training to CNX individuals.
- Support the Deviation, Complaints and Change Control systems, tracking status and following up outstanding or overdue CAPAs and generating metrics.
- May support Internal Audit Programme against an agreed schedule as a Support Auditor.
- Responsible for tracking and follow-up of audit/inspection CAPA actions.
- Monitor actions required from providers of stability data, ensuring timely delivery of reports to CNX. Follow up with suppliers as required.
- Support ‘inspection readiness’ as part of a cross functional team including pre-audit preparation and backroom activities for regulatory inspections and internal/external audits.
- Monitor the Quality Inbox and track & reconcile any incoming Product Quality Complaints (PQCs)/ Customer Communications
- Deal with telephone enquiries in a prompt, efficient and courteous manner. Notify recipients of any messages accurately and in a timely manner.
- Provide project support to the Scientific Affairs team as required
- Interact with internal and external contacts with a high degree of professionalism, treating confidential and commercially sensitive information appropriately.
- Undertake other tasks and duties as delegated from time to time from Senior Management.

**Skills knowledge and Qualifications**
- Experience working within a GxP regulated environment within a Quality Management System
- Previous experience of being audited / or having provided support to audits
- Previous experience of solid dosage forms and sterile products preferred
- Knowledge of relevant pharmaceutical guidelines and regulations in manufacturing and distribution
- Able to prioritise and manage multiple tasks in a fast-paced, dynamic work environment
- Strong communication and interpersonal skills, with the ability to collaborate effectively in a cross-functional environmentProactive, action orientated, pragmatic and solution focused
- Understands the importance of compliance and acts with the highest standards
- Good attention to detail

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