Location: County Armagh
Job Type: Contract
Date Posted: 18/07/2017
Do you have experience in Quality & Compliance?
Are you familiar with GMP Compliance?
Would you like to work for one of NI’s leading pharmaceutical companies?
We have a very exciting opportunity to join one of our prestigious clients based in Craigavon. If interested or would like more information then please call Alex on 02890 313157 or email email@example.com
What you will be doing:
- Monitor and review all manufacturing, quality control, analytical support, stores & distribution, product development, and engineering operations to assess ongoing GMP compliance and Quality of manufactured and released pharmaceutical products
- Actively assist all departments in the implementation of quality systems such as deviation / CAPA management, change controls and risk assessments; and ensure that quality systems are continuously improved with the objective of assuring the GMP compliance and quality of pharmaceutical products
- Internal/external contact for queries related to product compliance and quality
- Assist in monitoring and reviewing quality system elements such as deviation reports, corrective and preventative actions, change controls, complaints, audits, and out-of-specification reports, with the objective of assuring the GMP compliance and quality of pharmaceutical products
- Review production and laboratory data, which is used to release product, or review validation/stability reports to ensure that all information contained within, is correct and accurate
- Participate in the Supplier Management Process to assure that materials are appropriate for pharmaceutical manufacturing
- Identify, write, approve and implement critical GMP documents within Pharma Services and assist in training as required on new/ revised procedures
- Carry out internal audits on all Pharma Services related areas as per the annually approved schedule to ensure GMP compliance
- Assist and participate in audits of external suppliers as well as assist in hosting customer and regulatory audits as required
- Assist in the compilation and review of Product Quality Reviews/ Annual Product Reviews, Technical Agreements and Risk Assessments
- Additional duties related to the assurance of GMP compliance and quality of manufactured and released pharmaceutical products, may also be assigned.
What you will have:
- Significant experience working within an established Quality System (e.g. GMP, ISO)
- Demonstrable experience in Root Cause Analysis techniques or other investigational techniques
- Previous experience in writing and producing detailed reports
- Effective communication skills (both written and oral)
- Proficiency in use of IT applications (Word, Excel, Outlook, Project, PowerPoint etc)
- Excellent attention to detail
To hear further information on this role, contact Alex on 02890313157 or email firstname.lastname@example.org
Please submit your application or call the specialist consultant in Abacus Recruitment on 028 9031 3157 for a confidential career discussion or explore other jobs in Belfast, Northern Ireland, Dublin or London.
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