Cpl in partnership with our client SK Biotek are currently recruiting for a Quality Assurance Lead Specialist to join their QA Systems and Validation Team on a permanent basis. Reporting to the QA Systems and Validation Manger, the QA Lead Specialist will be responsible for managing and maintaining the sites documentation and quality management systems. 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:
- Managing the site computerised Documentation system, co-ordinating any configuration updates and escalating and resolving any technical issues in conjunction with IT.
- Ensure that controlled documents are managed in a timely and efficient manner according to procedure.
- Prepare and monitor the procedures necessary to operate an optimised document management system to best practice.
- Key point of contact for all local documentation procedures and initiatives.
- Ensure completed GMP batch records are filed and archived as per procedures and manage the relationship with the off-site storage vendor.
- Manage the recruitment, training and ongoing provision of the QA Administrator role in support of the document management system.
- Site SME and point of contact for all local Change Control procedures and initiatives.
- Act as Site Administrator for the Quality Management System (Trackwise).
- Responsibility for managing the Trackwise system, co-ordinating any configuration updates and escalating and resolving any technical issues in conjunction with IT.
- Compile monthly site quality metrics.
- Support customer and health authority Inspections.
- Actively contribute to continuous improvement initiatives including lean ways of working and the development and maintenance of metrics for trends and key performance indicators.
- Assessment of computer system changes for GMP compliance in accordance with the change control procedure for control systems.
- Review and approve control system Validation Master Plans, IQ and OQ protocols and reports.
The successful candidate will hold a BSc or BEng in Chemistry or a science related discipline, and should have a minimum of 5 years’ experience in a QA role. The successful role holder will be able to demonstrate excellent time management and organizational skills along with a proven ability to multi-task.
Experience in using and administrating Quality Management and Enterprise Systems is preferred but not required.
Knowledge of computer system validation and experience of approving VMP/IQ/OQ would be an advantage.
The QA Lead 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.