Quality Specialist and Deputy Responsible Person
We are looking to expand our Quality team based in our Dublin Warehouse!
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.
To support our growth, we are seeking a confident and proactive Quality Specialist and Deputy RP to join us, working directly with the Quality Manager to support the business in relation to all Quality matters detailed below.
Requirements- To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
- To assist in ensuring; that the appropriate standards of GMP and GDP are maintained.
- Origination, review, approval, maintenance and archiving of quality documentation. This will include but not be limited to for example Polices., SOPs etc.
- To assist in the organization and delivery of appropriate training is given in this area.
- Coordinate Quality Assurance raw data to ensure compliance with regulatory expectation.
- Collation of raw data to support monthly quality arrangement system indicator (QMS) reporting.
- As required contribute to the delivery of QA projects.
- Deal with QA enquiries promptly with due diligence.
- Ensure all quality critical documents are appropriately drawn up, maintained, reviewed filed and archived to ensure compliance with regulatory and customer expectations. Additionally, providing reports to the group head of Quality, Quality Manager and other nominated parties to show status and progress.
- Coordinate QA raw data including the following: Change Controls, CAPA Management, Deviation nvestigation, Temperature Excursion investigations, Product Discrepancy investigations, Product Recalls, product Quality Complaints
- QA lnbox Management
- Support the self-Inspection process
- Support the Supplier Approvals Process
- 27 days holiday plus 8 bank holidays
- Life assurance 4 x annual salary
- Annual salary review
- Independent financial advice service
- Long service awards
- Recognition scheme & employee of the year awards