About PSC Biotech Who we are? 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 point 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 of 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 though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.Role Description:The role of Quality Control (QC) Instrumentation Systems
Specialist at Dublin operates as part of a dynamic team to plan, execute, and
managing the activities required to maintain the testing infrastructure of the
QC lab.The team working style is one of collaboration, coaching,
and teamwork to provide Quality oversight and expertise to the QC team to
support a High Performing Organisation.Our Quality Control group ensures all materials used for our
products is manufactured, processed, tested, stored, and distributed aligned
with our incredibly high standards of quality, meeting all regulatory
requirements. Partnering across our internal manufacturing facilities, external
contract manufacturers and suppliers we create a global manufacturing network
committed to deliver a compliant, reliable supply to customers and patients on
time, every time, across the globe.RequirementsRole Functions:The QC Instrumentation Specialist roles and responsibilities
include but are not limited to the following:Responsible the qualification, maintenance, and/or
integration of the QC systems, in compliance with up-to-date data integrity,
regulatory, and industry standardsResponsible for change control process and mechanisms
required to maintain a state of continued compliance for the QC systems and
instrumentation.Support the QC department for troubleshooting,
investigations, and deviations as an SME.Manage deviations, CAPA’s and change control’s related to
the QC and team priorities.Assist with implementation of client Quality Chapters to
ensure we maintain best practices and build excellence into our QC systems and
processes.Author and revise local SOPs, work instructions, and
guidelines.Serve as an SME for regulatory and internal inspections and
audits.Motivation to be an inspiring member of a high performing
team with the desire to continuously learn, improve, and develop. Experience, Knowledge & Skills:Typical Minimum Education:A bachelor’s degree in Engineering, biological science, or
related field. Typical Minimum Experience:3 years’ experience in CSV and/or CQV for laboratory systems
and instrumentationExperience in regulatory audits.Working knowledge of biologics analytical methods and
specifications and Good Manufacturing Practice (GMP). Qualifications & Education:Technical:Strong CSV experience with analytical instrument maintenanceExcellent understanding of data integrity compliance
requirementsDemonstrated ability to drive complex tasks to completion.Strong organizational, problem-solving, and continuous
improvement skills Business:Ability to prioritize activities in line with the
maintenance schedules and business needs.Ability to maintain the flexibility to react to changing
business needs.Experience and understanding of the change management
requirements of validated systems and software.Excellent communication skills both verbal and written. Leadership:Ability to handle multiple projects and deliver on critical
deadlines.Demonstrated ability to work independently on own initiative
and manage time.Demonstrate ability to work with a team and co-ordinate work
to meet a common goal.A high level of self-motivation, knowledge, enthusiasm, and
drive.#LI-XA1