Technical Writer - Cleaning Validation SIPLimerick, Ireland | Posted on 11/12/2024
Industry: Pharma/Biotech/Clinical ResearchWork Experience: 2-3 yearsCity: LimerickState/Province: LimerickCountry: IrelandJob DescriptionAbout PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
'Take your Career to a New Level'
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech. We provide unparalleled empowering career development through Learning & Development, in-house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Technical Writer - Cleaning Validation SIP
An experienced Technical Writer is required to become a key member of the Cleaning Validation team within a renowned Limerick-based Biotech multinational. This is an excellent opportunity to develop your career while working in a dynamic, state-of-the-art facility.
RequirementsResponsibilities: Experienced Technical WriterExperience in Deviation and investigation writingExperience in Validation, specifically CIP/SIP and continuing validationExperience in assessment of CIP/SIP issues during study runs and closeout of deviationsExperience in KAYE validator reporting review beneficialCapable of managing a large program; project management skills are necessaryAn understanding of how manufacturing, CIP, and SIP Validation equipment worksGenerate/review/approval of SIP protocolsGeneration of Summary Reports and strong quality background essentialExperience in continuing validation and generation of assessments for continuing validationAssessment of the impact of issues/deviations arising through the assessment generationMaintain and update Cleaning/SIP Validation PlanSchedule of Cleaning/SIP activities with ManufacturingQualifications and Experience: Bachelor's Degree in Science or EngineeringExperienced in QA Validation activities – execution, review & approval of SIP/CIP and continuing validation protocols and closureExtensive experience in writing and approving DeviationsTechnical writing experience, including writing a number of white papers and site reportsTechnical writing experience for continuing assessmentsSkills: Cleaning Validation, SIP, CIP, Technical Writing
#J-18808-Ljbffr