Job Type: Perm
Job ID: JO-1908-19273
Consultant: Karen McHugh
Do you have 3+ years of experience in a manufacturing environment with sterile experience?
Would you like to work for a multinational Biopharmaceutical company based in Waterford?
If you have the relevant experience, please forward your CV to email@example.com for review or call + 353 1 7978720 to discuss.
QA Specialist - Sterile Manufacturing - BioPharma - Waterford
JobContax is a preferred supplier to one of the world's leading Healthcare companies.
With major capital investment happening in their Waterford plant, this is an exciting time to join the team.
Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
Implement and support a batch release system in the QA function of Sterile Manufacturing.
Support the development of GMP training packages and delivery of training
Participate in the preparation and review of procedures and batch documentation
Review and approval of deviation, CAPA’s, quality events and tasks
Ensure the quality system at Sanofi is effectively implemented and maintained.
Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
Work with relevant departments to ensure timely closure of quality actions / findings
Actively contribute to continuous improvement initiatives.
Conduct duties in a safe manner and report all safety issues or concerns
Bachelor’s degree in a science related subject is essential
3+ years experience in a manufacturing environment, sterile experience is preferable
Effective technical knowledge of sterile manufacturing processes
Operational experience of quality systems in a dynamic manufacturing environment
Knowledge of requirements for cGMP, US and EU regulatory requirements
Full understanding of relevant quality and compliance regulations
Able to manage projects to plan/budget
Good communication skills at organisation, team and individual levels
Understands KPI’s for the team and site
Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs
Salary Negotiable depending on experience
Excellent benefits package
Flexible working hours
Further education opportunities
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail firstname.lastname@example.org or phone +353-1-7978720
© 2018 JobContax All Rights Reserved