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Job Details

Senior Quality Specialist

Company: Thornshaw Recruitment
Reference: TD9985
Closing Date: 07 Jan 19
Type: Permanent
Salary (£): On Application

Job Summary:

On behalf of our client a global Pharmaceutical company we are accepting candidates for the role of Senior Quality Specialist.  


On behalf of our client a global Pharmaceutical company we are accepting candidates for the role of Senior Quality Specialist.  

In conjunction with the Quality Management team you will assist in the departmental processes for products and brands. This role will require a proven track record in Quality and Team Supervision 
•    Partners with the Regulatory Affairs, Supply Chain and Pharmacovigilance to assist and participate in the assurance of compliance activities required to ensure that products supplied by the company, are in accordance with cGMP their associated Marketing Authorisation, standards and values.  
•    Maintains and enhances cross-functional team relationships.
•    Participation in process improvement projects providing direct QA support throughout project execution.
•    Deputise for the Quality Manager and Deputy Manager when required.
•    Participation in project work.
•    Establishment and Maintenance of Training System, processes and procedures.
•    Responsible for PQR Sub-section approval. 
•    PQR Schedule compliance.
•    Complaint classification, review and approval.
•    Notification to Management.
•    Logbooks periodic audit.
•    Recall documentation.
•    Change Control Management.
•    Responsibility for site doc control system.
•    Closure of Deviations and CAPA.
•    Lead a team that consists of several Quality personnel and support the manager/deputy manager with:
?    Assigning, coordinating and reviewing of performance for day-to-day tasks allocated to the led team,
?    Determines priorities, timetables and assigns resources and tasks and is accountable for results,
?    Preparation of the regular reports regarding the assigned tasks/procedures progress,
?    Monitor operations to ensure compliance with dept. requirements,
?    Assessing the team training needs and preparing the training programmes while minimising cost and downtime,

Qualifications & Experience
•    Minimum 8 years Pharmaceutical experience. 
•    Quality Management system support.
•    Quality Assurance and Risk Management.
•    High Level of GxP (cGMP, GWP, GDP, GLP, GCP, etc.) knowledge.
•    Exposure to International Pharmaceutical Practices and Requirements.
•    Bachelor’s degree in science is preferred.  Associate degree with appropriate experience will be considered.
Experience in dealing with Regulatory compliance. 

For full details contact Tina at +353 1 2784671 or email
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Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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