QA Process Specialist
My client, a Global Leader in the Pharmaceutical market is looking to recruit a Quality Assurance Process Specialist to join their QA Team on a permanent basis. Reporting to the QA Team Lead, the QA Process Specialist will be working closely with the business functions to provide QA support.
Key Responsibilities
- Ensure all quality systems are implemented / executed in compliance with ICH Q7 and site quality standards.
- Review and approval of Manufacturing and Cleaning Batch Documentation and associated equipment logbooks in accordance with cGMP
- Batch disposition and preparation of certificates of analysis
- Pre-operative and routine inspections of the plants and facilities - shop floor presence.
- Review and approval of GMP SOP's, change controls and deviations.
- Participate in customer and regulatory inspections:
- Preparation of Campaign reports, Process Validation Reports, Process Verification Reports and Annual Product Reviews
- Compilation of Process and Cleaning validation protocols and reports.
- Communicate with all departments on site on a regular basis to ensure timely approval, use and shipping of product
- Support the introduction of New Products to site.
The QA Process specialist will be required to work on his/her own initiative as much as working as part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role. The QA Specialist will be committed to;
- Continuous improvement projects
- Leading initiatives and working with members of the Value Stream to drive efficiencies and to assure compliance standards for the site
*This position requires previous hands on experience working with small molecule API*
Education/Experience
The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 3 years pharmaceutical experience ideally in a QA role. The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task.
For more information please contact Jack on 01-6455250, or click apply below!