Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dundalk State/Province Louth Country Ireland Job Description About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide.
We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.'Take your Career to a new Level'PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry.
We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression.
We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview: A fantastic opportunity has arisen for a Validation Specialist.
The successful candidate will take a lead on utilising the latestinnovations in technology.
The role is based at the Drug Substance and Drug Product Facility which is a new facility build working to obtain qualificationand continued product development.
The site is the first facility in the network focused on manufacturing a live virusvaccine.
Requirements Responsibilities: Support the site validation activities across a number ofworkstreams.
Develop and maintain the site Validation Master Plan.
Drive development of site EMPQ strategy andimplement/maintain EM protocols and procedures for graded pharmaceutical areas,ensuring compliance with regulatory guidelines.
Perform/involved in risk based EM assessments todetermine the environmental monitoring requirements.
Oversee EMPQ validation studies, ensuring properexecution, data collection, and documentation.
Collaborate with production and quality control teams toestablish EM procedures, sampling routines and requirements.
Draft, review and approve validation documentation,reports, and deviation investigations.
Periodic classification of areas/EM programs to ensuretheir ongoing effectiveness.
Support equipment qualification post Operational Qualification (OQ) through to Process Performance Qualification (PPQ) andsubsequent revalidation.
Support global regulatory submissions, internal auditsand external inspections/audits as needed.
Facilitate problem solving & risk assessmentprojects/meetings.
Making problems visible and strive for continuousimprovement.
Lead and support various organizational initiatives asneeded (examples include safety, financial forecasting, work standardization,etc).
Keep up to date with scientific and technicaldevelopments.
Maintain continuous focus on quality and safetycompliance and unflinching focus on the customer.
Skills Required:3-5 years direct experience with a pharmaceutical orbiotechnology company with a working knowledge of current regulatoryrequirements and current Good Manufacturing Practices.
Bachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
Prior experience in Cleaning Validation, Temperature Mapping activities, and qualification of Parts Washers and/or Autoclaves.
Experience with upstream cell culture and/or downstreamformulation/fill finish processes.
Experience with technology transfer, regulatory filing,and commercial drug substance/drug product manufacturing of biologics.
Prior experience in drug substance/drug product, processperformance qualification and validation, site readiness and authoringregulatory CTD sections.
#J-18808-Ljbffr