QA Operations Manager
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | QualityManagement |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Telephone | 098-39159 |
| Job Ref | #2815 |
| Job Views | 852 |
- Description
- Team Horizon is seeking a QA Operations Manager for our Clients diverse team based in Dublin. our diverse team in Dublin. The Quality Operations Manager is responsible for ensuring that all products produced are manufactured in compliance with the requirements of GMP, end users, Regulatory Authorities, and company requirements.
Why you should apply:
This is an excellent opportunity to join a company with a track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:
Are you intrigued? Do you want to learn more?
Managing the Quality Operations group: manufacturing quality process support, validation and incoming materials release
Ensuring compliance by all departments and personnel with the requirements of the below during the manufacturing process:US Foods: and Drugs Administration, 21 Code of Federal regulations Parts 210 and 211 and Q7AICH Q7, Q8, Q9, Q10 and Q11.
European Commission, Good Manufacturing Practices, Volume 4, Medicinal Products for Human
Quality Assurance policies
Ensuring that products manufactured meet requirements of end users, Regulatory Authorities and of the company.
Liaising with above site and inter site Quality Assurance on quality related matters.
Ensuring Site Quality leadership are kept informed of operational failures to ensure corrective/preventive action is undertaken where required.
Working with Site Quality leadership to ensure site meets its customer, quality, service and regulatory goals.
Ensuring all plant personnel is fully aware of operational quality requirements.
Ensuring operations quality review on change requests are performed on operational/manufacturing-related changes.
Liaising with Quality leadership in monitoring performance of ER and CAPA process.
Verification of effectiveness of corrective/preventive actions arising out of product, and process exceptions.
Providing quality guidance, support and approval on all site/system validation activities.
Adheres to and supports all EHS standards, procedures and policies.
Works directly with the Quality Assurance Compliance Manager to support day to day site
Act as Designee for Associate Director Product Quality as required.
Any other duties as assigned
What you need to apply:
A Third level qualification in a science discipline with 8 years’ experience in the healthcare / pharmaceutical industry.
Degree or Masters level. Being QP-eligible is desirable.
8 years industrial experience gained in an FDA and EMA approved pharmaceutical or device environment.
Minimum 2 years supervisory experience.
Demonstrated Audit/ Inspection Management experience.
Requires total commitment to quality and maintaining a high standard of work at all times.