I am currently in partnership with an exciting rapid-growth start-up Pharmaceutical company in Central London. Together, we are looking for a Senior QA Specialist to join the team at their state of the art facility.
As Senior QA Specialist, your main purpose will be to ensure Quality Assurance regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner.
Secondly, you will supervise, manage and train the QA team and continuously improve the local Quality system and provide training & support for Quality relevant systems and set QA objectives for the QA team.
- Review Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.
- Perform internal audits and inspections and audit write up.
- Quality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality Incidents Deviations, CAPA's and Change Controls.
- Create and Review Standard Operating Procedures, Work Instructions and Policies.
- Deliver GMP training
- Provide guidance and assistance to quality related issues in Operational areas and to External third parties
- 4 years' experience of working within a GMP manufacturing environment.
- Understanding controlled processes.
- Proficient in Microsoft Office and experience in database use and eQMS systems
- Knowledge of GCP and GMP with regards to QMS activities
- Experience in Competent authority, Regulatory body inspections and audits
If you'd like to learn more about this position, please don't hesitate to get in touch ASAP!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales