What you need to know
Are you looking for the next step in your QA career? Do you have good working knowledge of Validations, HPRA, MHRA, EU regulations and ICH guidelines? Because we are looking for experienced candidates who have a QA background in the Pharmaceutical industry to join our Westmeath based client as a QA Compliance Officer.
This is a permanent job where you will work Monday – Friday, 8:30am – 5pm.
Your new job
The main functions of this role will see you working on product quality review, data tracking and trending and reviewing all Third-Party manufacturing activities to ensure compliance with license details and updated in accordance with relevant guidelines and directives. The role demands a well-organized approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and meet projects deadlines is essential.
Key duties & responsibilities:
- Develop work processes in conjunction with Quality Operations Manager and Release QP’s, to aid the release of medicinal product batches
- Review and approval of specifications/methods, Validation protocols, reports, manufacturing documentation, SOPs/forms and change controls as required supporting CMO operations
- Assist with the coordination and planning of API, Contract manufacturer and internal audits
- Complete risk assessments as required for key processes changes, new regulations and as required per NCR/CAPAs
- Track and review CMO Product Quality Reports (PQRs)
- Review and tracking of validations associated with Contract manufactured products
- Support maintaining and improving the Pharma QMS and CMO activity and ensuring that all aspects of the QMS meet GMP requirements.
What are we looking for?
- Third Level qualification preferably in a scientific discipline
- Minimum of 3 years’ experience in a Pharmaceutical QA role
- Experience with Validations is essential
- Good working knowledge and experience of Quality Management Systems in a GMP environment
- Good knowledge of HPRA, MHRA, EU regulations and ICH guidelines
Apply for this job now or get in touch with Gareth on 090 6490485.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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