J5630787LeinsterPharmaceutical Biotechnology CRO/CMO PermanentExperience dependentFull Time18/01/2019Quality Assurance Quality Assurance – Auditing Quality Assurance – Compliance Quality Assurance – GMP Quality Assurance - GDP IT – ERP IT - SAP Quality Assurance - GxP
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We are currently looking for a Quality Specialist to join a leading pharmaceutical company based in the Republic of Ireland. As the Quality Specialist, you will be responsible for the implementation, maintenance and development of the quality systems and standards to ensure product compliance to cGMP, and Market Authorisations.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Specialist will be varied. However, the key duties and responsibilities are as follows:
1. You will provide Quality support to the manufacturing areas in reviewing batch documentation, BMRs, investigations, risk assessments, OOSs, non-conformances, deviations, CAPAs and change controls, through the QMS.
2. As the Quality Specialist, you will assist the review of submission documentation in-line with customer requirements and licence applications, assist customer and regulatory inspections, and perform internal audits of manufacturing areas.
3. You will raise compliance gaps and improvements for continuous improvement of the site, prepare and review batches prior to QP release, and ensure that all site work complies and conforms to GxP standards, regulations, SOPs and HSE guidelines.
To be successful in your application to this exciting opportunity as the Quality Specialist we are looking to identify the following on your profile and history:
1. Relevant degree in Life Sciences / Pharmaceutical.
2. Proven industry experience working within a pharmaceutical Quality Assurance function and electronic document management systems.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.