Qualified Person (QP)
We are looking for a Qualified Person (QP) to join our team, reporting to the Lead QP. Ideally, you will be a registered EU Qualified Person with relevant experience in the pharmaceutical industry, but we are also interested to hear from anyone who is working towards this and looking for an employer to support them through the final stages of accreditation.
You’ll participate in all aspects of maintenance of the quality systems associated with the company’s manufacturing licenses (MS, MIA and MIA (IMP)) in use at our Quest 22 site in Doncaster. You’ll also undertake routine product and IMP certification as a Qualified Person in accordance with article 51 of 2001/83/EC and Annex 16 of Good Manufacturing Practice Part I (Eudralex volume 4).
Qualified Person (QP) Responsibilities:
- Assist in maintaining GMP, GDP and GCP standards across all site operations.
- Assist in the development and approval of new Standard Operating Procedures (SOPs).
- Assist in the generation and approval of production documentation.
- Assist in driving the change control process and assist in managing change as required including the provision of training against the needs identified.
- On a project basis, to lead or assist in the redesign of systems or premises.
- Take responsibility for specific areas of the quality system as required and agreed with the Lead QP.
- Assist in the introduction of new client work to site ensuring all processes have been adequately followed. Assist in ongoing maintenance of documentation.
- Ensure QPulse is being utilised as per Company directives and standards to record and monitor aspects of the QMS.
- To perform the review and certification as suitable for release for sale batches of product processed at the site.
- To perform the review and certification as suitable for use batches of clinical trial materials received onto site and those requiring further processing.
- Maintain familiarity with current industry practice and any changes to national or European legislation.
Qualified Person (QP) Requirements:
- Registered EU Qualified Person with relevant experience within the pharmaceutical industry.
- Detailed knowledge of current GMP requirements and working knowledge of current GDP requirements.
- Good understanding of the pharmaceutical manufacturing sector in the UK, EU and third countries.
- Experience of working with electronic QMS solutions, such as Q-Pulse.
- Excellent project management skills and demonstrate completer-finisher abilities.
- Capable and confident communicator (written and verbal) at all levels with first class presentation skills.
- Commercially astute and customer focused.
- Demonstrable analytical and problem solving abilities.
- Have a hands-on approach with an enthusiastic can-do attitude.
- Demonstrable coaching and mentoring skills.
Mawdsleys are a global pharmaceutical service provider offering a wide range of services to the pharmaceutical industry and healthcare sector. We are the largest independent pharmaceutical wholesaler in the UK with a fast growing international network supplying medicines to meet patient needs and providing a route to market for manufacturers. We are fully managed and regulatory compliant sourcing imported medicines for specific patient needs.
Location: Doncaster, South Yorks
Type: Full time, Permanent
Salary: Up to £70,000 per annum dependent on experience