We are supporting a fast growing pharmaceutical company who are in need of a QA Specialist on a long term temp basis.
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. This is an onsite role Monday to Friday with flexible working hours.
- 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/KPI 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 Sterling 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.
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.
Trained external auditor for external suppliers.
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.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
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