A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Qualified Person/QP. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's UK office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
- Developing new product ideas with customers by monitoring customer needs (ensure, that products fulfil their requirements) and to identify new business opportunities to propose product extensions or new product ideas.
- Supporting and contributing to product development projects from project start to the availability of verified and validated products for sale.
- Monitoring revenues, profitability, quality, and availability of products though product care meetings and steer product life cycle through the change management process.
- Collecting product-related customer feedback and feeding improvements/corrective actions into product life cycle management processes.
Skills and Requirements:
- MSc in a Life Sciences discipline. 7 years hands-on experience gained in both Quality Assurance and Quality Control departments.
- BSc or equivalent in a life sciences discipline, chemistry, or biochemical engineering.
- Qualified Person (under permanent provisions). 5-7 years hands-on experience gained in both Quality Assurance and Quality Control departments.
- At least 3 years in a Supervisory position.
- Thorough knowledge of cGMP guidelines gained through practical experience of supporting cGMP manufacturing operations.
- Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. Preparation for FDA and EMA inspections.
- Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.
- Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steven Fuller at +44 203 871 8091 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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