Job Description
My client a leading Multinational Pharmaceutical company now require a Quality Assurance Manager to join their expanding team.
The Quality Assurance Manager will work closely with other Quality Department personnel as part of the site Quality Department. The Quality Assurance Manager (Bioprocessing) may assume responsibilities in any of the Quality Department pillars, in accordance with business needs.
This is a permanent role based in Dublin.
Responsibilities of Quality Assurance Manager
Management of the Quality Assurance (Bioprocessing) team, including Qualified Persons.
Management of batch record review, batch disposition and material status control activities associated with the biologics 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 (Bioprocessing) 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.
Communication and liaison with other departments on Quality issues (as required), providing guidance and support to others.
Motivation, training, discipline and appraisal of Quality Assurance staff.
Acting as a designee to the Site Quality Head as required.
Requirements of Quality Assurance Manager:
Primary Degree in Scientific discipline:
More than 7 years' experience working 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.
Follow us on Twitter, Facebook and LinkedIn
The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below