GxP Systems, a leader in regulatory compliance consultancy and project management services, enables medical device, biotechnical and pharmaceutical clients to systematically and continuously lower the cost of compliance within their discovery, manufacturing, and supply chain facilities, without compromising compliance or quality.
We are currently looking for a Validation Engineer to join our team. The ideal candidate will have previous experience in a similar validation role in the pharmaceutical or medical device industry.
Responsibilities:
Co-ordination, implementation and active participation in the site validation programme Develop validation documentation as required (e.g. specifications, plans, protocols, procedures etc.) Review and approve documents prepared by the validation team and other departments (e.g. commissioning test plans, impact assessments, change controls) Initiate and implement change control activities in accordance with site procedures Represent validation department at internal and external audits and support quality assurance programmes Execute qualification protocols as required and prepare reports Co-ordinate re-validation activities and generate SOPs / other documentation as applicable Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements
Qualifications and Experience:
A degree qualification in science or engineering is desirable Strong knowledge of CSV/GAMP,21CFR Part 11,Project Life Cycle and cGMP Regulations Ability to apply cGMP regulations and guidelines to all aspects of qualification activities Strong technical skills Ability to organize, plan and execute multiple tasks to a schedule Excellent interpersonal and communication skills Self starter / takes initiative Team player To apply for this role please send your CV to grainne.killilea@gxpsystems.com
