Technical Writer

PE Global is recruiting for a Technical Writer on behalf of our pharmaceutical client in Limerick. This is an initial 12-month contract role. Summary: Performs all technical writer related tasks necessary for the creation and maintenance of quality GMP documentation in support of the Technical Operations Engineering and Automation Department. Essential Duties and Responsibilities include, but are not limited to, the following: ? Collaborate with subject matter experts and key functional department personnel to ensure timely development and accurate content of GMP documents (e.g. standard operating procedures, system design documents, and work instructions) ? Perform retrospective assessment of computerized system administration activities and author the resulting reports. ? Maintain an awareness and understanding of current site document requirement, document control procedures, and good documentation best practices. Review internal GMP documents to ensure they are compliant with these expectations and suggest improvements. ? Manage and coordinate activities related to document creation using the Electronic Document Management System, including document initiation, workflow support, revision, and retirement. ? Conduct compliance review of electronic work tickets for adherence to Good Documentation Practices/Requirements ? Facilitate cross-functional collaboration of cGMP documentation with technical experts and stakeholders to reach consensus and ensure document approval timelines meet business needs. ? Own and/or support GMP document-related Change Controls/CAPAs. Education and Experience: ? Associate Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field or equivalent combination of education and experience. ? Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field and 2 years of relevant experience or equivalent combination of education and experience. ? Senior Technical Writer: Requires BS/BA in Life Sciences, Engineering, English or related field and 5 years of relevant experience or equivalent combination of education and experience. Knowledge, Skills, and Abilities: ? Strong knowledge of Good Documentation Practices (ALCOA), ISPE Standards, GAMP5, and Documentation Management/Life Cycle guidance ? Applies excellent collaboration skills, via multiple communication types, in a steady-paced environment. ? Strong writing and proofreading skills in a technical and scientific capacity. ? Ability to organize and author technically complex information into laymen suitable documentation. ? Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes. Interested candidates should submit an updated CV. Please click the link below to apply, call Paul Wheatley on or alternatively send an up-to-date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: GAMP5 GMP Alcoa