Quality Assurance Senior Specialist

Cpl in partnership with our client SK Biotek are currently recruiting for a Quality Assurance Senior Specialist, on a permanent basis. Reporting to the Quality Assurance Systems and Validation Manager the QA Senior Specialist will be working closely with the business functions to provide QA Systems and Validation support. This role is a great opportunity to work as part of a dynamic team across multiple aspects of Quality and the broader SK biotek site. Significant experience will be gained through the multiple interfaces and projects in this role. This is an exciting opportunity to join a pharmaceutical company with over 50 years of API manufacturing experience.

Responsibilities include but are not limited to:

•            Proactively participating in all areas of QA Systems and Validation team, cross training in areas such as, validation (computer and equipment), QMS software management (TrackWise, LIMS, DCA) and documentation management to form a high performing flexible team.
•            Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
•            Review of master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
•            Support the execution of the site Internal Audit Process and Inspection Readiness Program
•            Ensure Technical Agreements are in place for outsourced services
•            Actively contribute to continuous improvement initiatives including lean ways of working
•            Support the development and maintenance of metrics for trends and key performance indicators across the Quality Management System
•            Preparation, review and approval of GMP documentation.

Required Key Skills and Experience:

•            Excellent communication and organisational skills with demonstrated expertise to effectively communicate within all levels of the organisation is required.
•            Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 2 years pharmaceutical experience ideally in a QA role. Preferably with experience in change control/documentation management, good manufacturing practices
•            Knowledge / appreciation of other site operations such as QC, Operations, Engineering, IT.
•            Some experience in Operational Excellence or project management would be desirable.
•            Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.

WHATS IN IT FOR YOU?

•            A chance to work with a world leader in contract development and manufacturing in a fast passed, dynamic and growing company
•            Excellent opportunities for career enhancement and personal development
•            Competitive base salary
•            Annual bonus linked to base salary
•            A well-established further education program.
•            Pension scheme
•            Private health insurance
•            Free onsite parking
•            Subsidised canteen on site