About PSC Biotech Who are we?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 PropositionEmployees 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. Overview:An amazing opportunity for a Quality Assurance Specialist
to join our quality team. In this role, you will play a vital role in
supporting the introduction of new products and Quality oversite of executed
validation completed.As the QA Specialist for Validation and New Product
Introduction (NPI), you will be an essential member of our esteemed Technical
Transfer/Validation Team. This team holds responsibility for managing the
development and manufacture of vaccines and biological products. Alongside your
day-to-day QA activities, your main focuses will be reviewing and approving all
Validation documents relating to a sterile facility including cleaning
validation ensuring to support corporate compliance and regulatory expectations
for manufacturing.You will report to the Associate Director of Quality and
collaborate closely with cross-functional teams on-site, particularly Technical
Engineering. Your key objective will be to ensure that manufacturing,
technical, and regulatory requirements are met.RequirementsResponsibilities:Provide quality oversight and direction for the
introduction of new products.Serve as the point of contact for quality at both the
site level and with external inputs, coordinating and attending Quality working
group meetings.Participate as a functional expert in the
cross-functional team responsible for introducing products.Conduct quality reviews and approvals of
engineering/validation/automation/utilities commissioning and qualification
activities.Author, review, and approve protocols and reports for
technology transfer, method qualification, and method validation.Review documentation associated with new product, such
as, QC Test Specifications, BOMs, and MES documentation.Support deviation close out in a timely manner.Facilitate compliance direction for the site by adhering
to divisional policies, guidelines, and regulatory requirements. Proactively
evaluate site compliance against emerging trends and initiate major compliance
initiatives for improved status and operational efficiency. Actively
participate in Plant/Quality committees and collaborate with other site
functional groups.Skills & Education Required:A Bachelor's degree or higher in a related Science
discipline is preferred.A minimum of 3-5 years of experience in a quality role,
ideally in a pharmaceutical manufacturing environment.Knowledge of regulatory/code requirements related to
Irish, European, and International Codes, Standards, and Practices.Familiarity with cGMP (current Good Manufacturing
Practice) and GDP (Good Distribution Practice) is preferred.Strong report, standards, and policy writing skills.Experience with equipment and process validation.Familiarity with sterile filling processes and equipment.Proficiency in Microsoft Office and job-related computer
applications.Experience or familiarity with Lean Six Sigma methodology
is desired.Good collaboration skills and the ability to work
effectively as part of a team to determine priorities.Demonstrated ability to work independently and take
ownership of improvement initiatives with a moderate level of guidance.Proven ability to drive the completion of tasks.Strong decision-making capability with a sense of
accountability and responsibility.Demonstrated problem-solving skills. Reporting To: Associate Director of Quality #LI-AP1