RRxCo is partnered with an exciting and fast-growing Biotech to hire a QA specialist to help bolster their resource.
The UK-based business established in 2010 focusing on antibody, protein and peptide drug conjugate medicines and technology. The bioconjugation team was formed in 2011 and moved into a state-of-the-art facility in 2018. The facility has been built for containment; with the safety of their people and the environment in mind, and bespoke laboratories have been designed specifically to accommodate highly potent bioconjugations.
Antibody Drug Conjugates combine the cell and tissue specificity of monoclonal antibodies with the cell-killing potential of highly potent small molecules and represent one of the fastest-growing sectors in the oncology field.
Summary
The Quality Assurance Specialist is responsible for maintaining the quality management systems, ensuring there is adequate QA support for production activities (including batch review), Project support, oversight of material management and approval of materials/ service providers, approval of validation documentation, audit support activities and other QA activities onsite.
Deliverables
- Responsible for document review (batch documents, logbooks, Protocols, SOPs, forms etc.)
- Use Quality systems to ensure compliance (Documentation, Deviation CAPA, Change control etc)
- Contributes to supplier quality assurance programme and new supplier qualification.
- Supporting and leading quality related investigations, writing investigation reports and initiating/following up on corrective and preventative actions.
- Use, support and maintain training systems, training programmes and training documentation.
- Proactive administration of the Quality Management systems, metrics/KP! management and trending for Quality.
- Works closely with all functions and departments to ensure efficient document review according to cGMP and other regulatory requirements are compliant.
- Supports and lead in self-inspections, customer, and regulatory audits.
- Is an integral part of the Quality Team, Coach, support and follow values.
- Ability to work under pressure and leading Quality based projects.
- Support and lead other activities like Data Integrity activities, Quality Risk Management, approving pre and post execution validation documents, Supporting batch release of clinical and commercial bulk drug substance/ API against product specification files.
- MHRA and other regulatory guidelines knowledge
- Completion of additional duties reasonable to ensure the efficient running of the QA department.
Profile of the individual
- Minimum HND Biological subject and have a proven track record in QA in the pharmaceutical industry (or a related industry)
- Minimum 5 years' experience in a QA role within either Pharmaceuticals or Biopharmaceutical environment. QA experience of dealing with QC and/or Manufacturing would be advantageous.
- Experience using Microsoft Office of programs especially good knowledge in Word, Excel, PowerPoint, and formatting skills.
- Knowledge and practical experience of GMP & GLP Systems.
- Knowledge and practical experience of Quality systems, Data Integrity, Supplier Management and Quality Risk Management.
- Numerical & investigative skills, Coach and support other functions in managing quality issues. Ability to work accurately, with attention to detail in documentation reviews.
- Ability to prioritise and deal effectively with a varied workload.
- Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation.
- Approachable and friendly, with the confidence to constructively challenge results and performance when required.
Desirable:
- Trained external auditor for external suppliers. Trained trainer, mentor, and coach in Quality.
- End to end QA knowledge on pharmaceutical manufacturing knowledge. Excellent technical reports writing skills, advanced Microsoft package skills. Leadership and soft skills proficiency.
- Investigational Medicines product knowledge of Manufacturing and QA support.