Job Type: Perm
Job ID: JO-1901-12485
Consultant: Karen McHugh
Are you a QA specialist with pharma experience in solid oral dose manufacturing?
Are you looking for an opportunity to develop your career in a management capacity
Would you like to work for a multinational Biopharmaceutical company based in Dublin West?
QA Executive - Batch Release - OSD - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their plant, this is an exciting time to join the team.
The Quality Assurance Executive is responsible for managing the Quality Assurance team associated with production of oral solid dosage product in the production facility at our client's Dublin site.
In accordance with business needs, the Quality Assurance Executive may assume responsibilities in any other work area of the Quality Department.
The responsibilities of the Quality Assurance Executive include the following:
Management of the Quality Assurance team.
Management of batch disposition and material status control activities.
Management of review of Batch Manufacturing Records (BMRs).
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 routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance.
Ensuring effective participation of the Quality Assurance 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 TILGC 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 Quality Assurance Manager as required.
Ensure timely completion of all SOP, reading, training and assessment.
Primary Degree in a scientific discipline
Minimum of 5 years’ experience in the pharmaceutical industry in a Quality role.
Experience of oral solid dosage manufacture.
Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for oral solid dosage pharmaceutical manufacture.
High level of initiative.
Excellent verbal and written communication skills.
Strong project management and organisational skills.
Ability to adapt to changing priorities.
People management experience is desirable but not essential.
Total Package €60 - €70K
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 Karen by e-mail firstname.lastname@example.org or phone +353-1-7978720
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