Senior Specialist - Quality Assurance
My client, a Global Leader in the Pharmaceutical market is looking to recruit a Senior Specialist to join their QA Team on a permanent basis. Reporting to the QA Team Lead, the Senior Specialist will be working closely with the business functions to provide QA support. The successful candidate will have a critical function in identifying, managing and participating in process development activities to optimise existing production processes and procedures to improve quality, increase yields, reduce cycle times and costs.
An exciting and challenging position that offers excellent career development and progression, this is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical industries.
Key Responsibilities
- Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations
- Act as Quality point of contact and decision maker during Technology Transfer and Process Validation activities whilst ensuring that all activities meet internal and regulatory expectations
- Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc
- 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
- Pre-operative and routine inspections of the plants and facilities - shop floor presence.
- Review and approval of GMP SOP's, change controls and deviations
- 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
- Co-ordinates and approves the preparation of reports for PQR's including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes
The Senior 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 and will be a key function in;
- Continuous improvement projects
- Leading initiatives and working with members of the Value Stream to drive efficiencies and to assure compliance standards for the site.
Education/Experience
The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 5+ 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.
Previous experience in API, project and people management, or validation highly preferred.
Interested?
Please apply with your CV below or contact Jack on 01 645 5250 for more information!
