Proclinical is advertising a vacancy for a Quality Assurance Officer, External Manufacturing position with a specialty-driven biopharmaceutical group at their office in Berkshire. The company, which focuses on innovation and Specialty Care, develops and commercialises innovative medicines in three key therapeutic areas - Oncology, Neuroscience, and Rare Diseases. Exemplifying this is their growing portfolio, which includes therapies for prostate cancer, neuroendocrine tumours, renal call carcinoma, and pancreatic cancer. This is an exciting opportunity for an applicant to develop their career an innovative and transformative player in the neuroscience field.
The Quality Assurance Officer is responsible for the provision of QA support to the EMO team for all Drug Substance and Drug Product manufacturing and testing activities performed at Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs). They provide direct support to the QA Managers in the management of the day to day aspects of the QA Department, including batch record reviews, document management, PQR Authoring, and participating in quality-based projects. They will assume responsibility for providing QA Support and maintenance of various Quality systems, metrics, and documentation. The Quality Assurance Officer will provide support on product manufacturing, testing to Third-Parties, and to the Technical and Regulatory CMC functions within the company's External Manufacturing Organisation.
Job Responsibilities:
- Carrying out the follow-up of the action plans associated with the audits of suppliers and subcontractors.
- Updating the quality indicators (KPI) to monitor the quality performance of the various subcontractors and suppliers.
- Managing EMO Quality Data.
- Maintaining oversight/delivery of the Quality Management System.
- Generating and analysing the periodic quality reviews (PPR) sent by suppliers and subcontractors in accordance with the procedures in place.
- Completing the control charts and indicators associated with monitoring the quality of the outsourced products.
- Producing PQR summary documents for review by the QA Manager.
- Implementing all the activates related to the handling of complaints & deviations in accordance with the applicable company procedures, including:
- Receipt and Analysis from subsidiaries.
- Coordinating investigations with subcontractors and approving their conclusion.
- Approving the proposed action plans to address the root causes.
- Monitoring the effectiveness of proposed actions.
- Implementing activities related to the establishment and updating of the technical documentation, including Specifications and SOPs.
- Providing monitoring of the performance of the Quality Management System.
- Archiving Quality Documentation.
- Assigning training materials to EMO team members.
- Maintaining and updating Key Performance Indicators.
- Generating the Quality Management Review.
- Maintaining of the departmental training files.
Skills and Requirements:
- At least three years of pharmaceutical Quality experience, ideally with experience in a 'virtual' manufacturing environment.
- Experience in manufacturing and testing technology transfers involving CMOs/CTLs.
- Capable of building strong collaborative relationships with SMEs at CMOs/CTLs.
- Demonstrable competence in Pharmaceutical Quality Regulations.
- Demonstrable competence in Quality Management System Implementation.
- Experience with Risk Analysis.
- 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 in MS Office.
To Apply:
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 Josh Godden at +44 2038540101 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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