Located in the UK, ideally commutable to one of PLx’s UK offices in Buckinghamshire, Hertfordshire or Cornwall.
To provide key support to the Director/Senior Consultant in all matters relating to the provision of services to our client and customer base.
The main focus areas for the role will be on technical delivery of client projects, both individually and as part of a team and will also include acting as a QP/RP/RPi for client projects in the UK. This role will report to the Director/Senior Consultant
Under the Guidance of the Senior Consultant
- To liaise with customers with regard to their requirements, determining their needs and timelines and to manage client projects including the preparation of project proposals and the implementation of Project Plans including timelines and costings.
- To conduct Quality Audits for Customers in line with PharmaLex auditing procedures and in line with all Pharmaceutical Regulatory requirements and standards, to highlight deficiencies to the customers and to support (as required) in the remedy of those deficiencies.
- To act as a QP/RP/RPi as nominated on client authorisations
- To advise and support companies in the establishment and improvement of their Quality Systems.
- To follow-up with existing customers to ensure satisfaction with service.
- To act as RP/RPi for clients in the UK. The RPi is responsible for:
- Ensuring that medicinal products have been QP released in accordance with Article 51 of Directive 2001/83/EC
- Completing supply chain check to ensure the batch is not subject to recall or reported as stolen and is available on the market in the listed country’s licensed supply chain.
- Confirming the status of unique identifiers for Prescription Only Medicines (per Commission Delegated Regulation EU 2016/161) if required for parallel import, special clinical need or for introduction.
- Ensuring that any additional requirements imposed on certain products by national law are adhered to.
- Technical management of client projects ensuring the completeness of project plans, correct allocation & implementation of timelines and project costings. To ensure all personnel and Associates are aware of their responsibilities and to monitor progress against key milestones / activity dates and report on progress to the Director/Senior Consultant and Project Team.
- To prepare draft training material for external class-room based courses and for web based e-learning and downloadable training material.
- To co-deliver / deliver training to clients.
- To undertake ongoing Continuing Professional Development (CPD) to ensure currency of technical knowledge and skills. This includes the development and maintenance of a Technical Reference Library at PharmaLex.
Business Development / Sales & Marketing
- To keep abreast with changing Regulatory Standards, Industry Best Practice and emerging trends to provide input to business development and product development opportunities.
- To follow-up with existing clients and potential new clients to increase client base and increase sales.
- To prepare draft company publications including the Regulatory Update Bulletin and e-Newsletter, liaising with Associates, Industry personnel / sources to gain input and ideas for content.
- To input as requested into the annual budgeting process.
- To deal with internal/external customer contacts and resolve queries and problems in an effective manner and timely manner.
- To liaise with Clients, regulatory authorities and other external parties as required / requested on behalf of clients and/ or on behalf of PharmaLex.
- To ensure compliance with all PharmaLex company policies and procedures, including Quality Systems, and E, H&S requirements.
- To ensure all documentation prepared is in line with standards as set down by relevant Legal and Regulatory bodies.
- 3rd Level Qualification in Science or Quality Management.
- 10 yrs experience in Quality Assurance or Quality Compliance role – GMP/GDP.
- High level Computer Literacy and competency – Microsoft Office, Microsoft Project.
- QP or RP Status.
- Vendor Auditing Experience.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Ms / Mr Farrell
Office Manager/ Senior Specialist
Agencies only by prior agreement for the specific job opportunity.