Job Type: Perm
Job ID: JO-1908-19285
Consultant: Karen McHugh
Do you have Quality Compliance Management experience in a Pharma or Biologics Manufacturing environment?
Would you like to work for a multinational Biopharmaceutical company based in Dublin?
If you have the relevant experience, please forward your CV to email@example.com for review or call 353 1 7978720 to discuss in confidence.
Senior QA Associate - Compliance - Biologics - 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 Compliance Executive is responsible for the coordination of compliance activities within the compliance group and for varying duties as assigned by the Quality Systems and Compliance Manager.
Supervisory duties for Quality Compliance personnel within the Quality Compliance group.
Provide oversight and management of elements of the Quality Management System (QMS), which includes, but not limited to, inspection management, metrics/KPIs, Product Complaints, Quality council, product quality communications, Regulatory Compliance, commitment and risk management.
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.
Preparation of Key Performance Indicators to align with company and global quality objectives.
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.
Participation in the preparation of documentation for regulatory submissions.
To ensure that the systems with a GMP impact are maintained as per written procedures.
Assist in 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.
A minimum of 5 years’ experience in a people management role 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.
Basic Salary: €55K+, open to negotiation for the right candidate
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 firstname.lastname@example.org or phone +353-1-7978720
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