QA Validation Specialist - Pharma - Dublin - 3 Days P/W - 3 Months

Meet Recruitment Ltd
United Kingdom
?500 per day
09 Oct 2017
07 Nov 2017
Contract Type
Full Time
This multinational Pharmaceutical company is looking for a contractor that is experienced in GMP QA review of Validation documents to come in and hit the ground running on a 3 month contract. This part-time role, working 3 days per week, is based at their manufacturing site in Dublin, Ireland. This is a fantastic opportunity to get on board with a company that has a global presence in the industry and has a reputation as being a great company to work for. Background My client is building a brand new high-containment production facility for a high profile drug that is in a Phase 3 clinical trial. The API is a highly potent material, therefore the manufacturing site will be designed for high-containment in order to achieve their target of 1µg/m3 containment. Role Responsibilities Working as a QA Validation Consultant your main responsibilities will be: - Approval of the validation documentation drafted by various departments (QC, manufacturing, engineering) - Ensure that all QA activities relating to Validation are carried out in accordance with approved procedures. - Ensure the scientific integrity of the Validation study and ensure Validation work is completed to GMP compliance. - Final approval of Validation documentation. - Ensure that all compliance activities in relation to Validation are carried out in accordance of Helsinn internal procedures and industry standards. - Approval of Validation deviations. Suitable For This role is ideal for a consultant that has experience working in a high potency manufacturing environment and is also experienced with solid-dosage tablet production. If you have experience of writing and reviewing validation protocols for manufacturing equipment and conducting QA review of said protocols and manufacturing documentation you will be ideal for this opportunity! Skills Required - Bachelor's degree in science, pharmacy, biological science or related field is preferred. - Hands-on international Quality Assurance experience in a solid-dose tablet manufacturing environment is essential - Experience working with high potency products from QA/Validation perspective is essential. - Strong understanding of cGMP requirements and the ability to implement and actions needed to implement this within the QMS. - Experience of writing and executing validation protocols for solid-dose manufacturing equipment (DQ, IQ, OQ, PQ). - Excellent verbal and written communication skills, ability to work well in teams or independently and the ability to prioritise work and manage multiple projects while maintaining quality and compliance. Commutable Locations: Republic of Ireland, Dublin. Rate: Competitive
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