Job Type: Perm
Job ID: JO-1908-19283
Consultant: Karen McHugh
Are you a Quality Assurance Manager with more than 7+ years’ experience working an aseptic environment in the Biotech / Pharmaceutical industry?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Quality Assurance Manager - Cell Therapy - Dublin West - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their Irish plants, this is an exciting time to join the team
The Quality Assurance Manager (Cell Therapy) will work closely with other Quality Department personnel as part of the site Quality Department.
The Quality Assurance Manager may assume responsibilities in any of the Quality Department pillars, in accordance with business needs.
Management of the Quality Assurance team, including Qualified Persons.
Management of batch record review, batch disposition and material status control activities associated with the Cell Therapy product.
Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
Management of the Change Control process, ensuring controlled implementation of all GMP related changes.
Management of QA oversight of manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
Ensuring effective participation of the Quality Assurance ((Cell Therapy)) team in production and other site meetings.
Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
Participation in the site Internal Audit programme.
Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
Motivation, training, discipline and appraisal of Quality Assurance staff.
Acting as a designee to the Head of Quality for Cell Therapy as required.
Participate fully in any cross functional training initiatives.
Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
Ensure timely completion of all SOP, reading, training and assessment.
Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
Primary Degree in Scientific discipline
Qualified Person status is highly desirable but not essential
More than 7 years’ experience working in an aseptic environment in the pharmaceutical industry, preferably in a Biologics company
Minimum of 3 years’ experience in a people management role
Excellent knowledge of Good Manufacturing Practice for aseptic pharmaceutical manufacture as described in current FDA & EMEA regulations.
Demonstrable experience managing, motivating and leading a team.
A high level of initiative is required
Excellent verbal and written communication skills are essential.
Strong project management and organisational skills.
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
© 2018 JobContax All Rights Reserved