A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Quality Assurance Manager & Qualified Person - External Manufacturing Department. 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.
- Deploying and maintaining GxP Quality Management Systems with CMOs and Testing Laboratories to ensure compliance with regulations and inspection readiness at all times.
- Deploying and maintaining a Quality Auditing capability with use of CAPAs to identify and track required improvements.
- Ensuring that critical quality issues are reported to company management using the Global Quality alert process.
- Reviewing and signing-off of master production, process validation and cleaning validation documentations provided by CMOs.
- Carrying out the disposition of Finished Products, APIs, Raw Materials, and Components when required.
- Developing a quality strategy aligned with the overall business strategy.
- Reducing and mitigating product risks.
- Developing opportunities for improvement.
- Identifying risks associated with company products and systems.
- Appropriately remediating and mitigating risks associated with company systems & products.
- Identifying and implementing opportunities to simplify EMO business processes, including sampling, testing, and data generation.
- Supporting initiatives to meet or exceed Quality objectives.
- Contributing to continuous improvement, planning, and execution.
- Contributing to the deployment of the Global Technical & Quality roadmap for External Manufacturing.
Skills and Requirements:
- At least a BSc or equivalent in a Life Sciences discipline, such as chemistry or bio. An MSc would be preferred.
- 7 years hands-on experience gained in both Quality Assurance and Quality Control departments with at least 3 years in a Supervisory position.
- Qualified Person (under permanent provisions).
- 5 years hands-on experience gained in both Quality Assurance and Quality Control departments.
- 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, and 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 Katty Maia at +44 2038543317 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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