Cpl in partnership with our client SK Biotek are currently recruiting for a Quality Assurance Specialist to join their QA Operations Team on a temporary basis. Reporting to the QA Operations Team Lead, the QA Specialist will be working closely with the business functions to provide QA support. 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:
• Working as part of the QA Operations team to ensure that customer products are manufactured, stored and packaged in accordance with cGMP.
• Review and approval of documentation associated with the manufacture of Commercial and New Investigational Products.
• Review and approval of manufacturing and cleaning batch documentation and associated equipment logbooks in accordance with cGMP.
• Responsible for the batch disposition of Commercial and New Investigational Products.
• Participate in the preparation and review of procedures and batch documentation including process risk assessments.
• Support the quality culture on site through actively supporting operations on the shop floor
• Actively contribute to continuous improvement initiatives including lean ways of working and the development and maintenance of metrics and trends and key performance indicators.
The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 1 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.
The Quality Assurance Specialist will be required to work on their own initiative as much as working a part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role.