Job Type: Perm
Job ID: JO-1908-19284
Consultant: Karen McHugh
Do you have 10+ years working within quality in the pharmaceutical industry?
Do you have experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas?
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 Systems Specialist - Change Control - 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
Provide oversight and management of key elements of the Quality Management System (QMS), which include, Supplier Quality Management and GMP training.
Supporting other elements of the quality systems group, including but not limited to, change control, deviations, CAPAS, documentation.
Provide oversight and management of the supplier approval programme and the external audit schedule.
Participate in the internal audit schedule.
Administration/co-ordination of risk assessments.
Develop and write SOP & Controlled Documents.
Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site.
To ensure that the systems with a GMP impact are maintained as per written procedures.
Assist and co-ordinate implementation of global standards and procedures into the site Quality Systems.
To actively support the development/implementation and continuous improvement of the Quality Management Systems.
To be cross-trained in multiple quality systems.
Participate in other projects as directed by the Quality Systems & Compliance Manager.
Participate fully in any cross functional training initiatives.
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.
Bachelor's degree in chemistry, biology or a related scientific discipline.
A minimum of 10 years working within quality in the pharmaceutical industry.
SME in Supplier Quality Management and GMP training is desirable.
Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
Thorough understanding of quality systems and cGMP's.
Excellent verbal and written communication skills.
Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
Work directly with other key departments to ensure compliance and productive working relationships.
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
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