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:This position within the QA department will provide
Quality oversight, support and knowledge to activities relating to Quality
Systems across the site and in meeting the priorities of: Compliance, Supply,
Strategy and Profit Plan.The team working style is one of collaboration, coaching
and facilitation to ensure the success of the site. The Quality Specialist is
accountable for the Quality Systems within the site.This role requires the delivery of a robust Quality
Management System to support a flexible, collaborative, multi-skilled teamwork
environment.The Quality Specialist will have proven capability in
development of Quality Systems as an active member, across cross functional
teams, to deliver process improvement. The Quality Specialist will model the Leadership
behaviours and understand the MPS principles to drive a culture of continuous
improvement building a High-Performance Organisation.The Quality Specialist will participate and comply with
the Quality Management System (QMS) requirements, including ownership as
required.RequirementsPrimary Responsibilities:Provides to the site expertise in Quality Systems and/or
Operational Quality, including the following i.e. Quality
Notifications/Investigations/ Change Management; environment monitoring
programs; sterility assurance/low bioburden manufacturing; etc.Uses knowledge to improve Quality Systems and/or
Operational Quality; solve complex problems, provide continuous improvement and
execute tasks.Acts as a resource to colleagues with less experience in
Quality Systems and/or Operational QualityUnderstands and applies regulatory / compliance
requirements to their role together with remaining current on upcoming
regulatory and compliance changesRequired to be proficient in Quality approval and
oversight for Commissioning and Qualification activities (IQ/OQ/PQ)Interprets customer needs, assesses requirements and
identifies solutions to non-standard requests.Makes decisions within guidelines and policies which
impact Product Quality, Projects and Quality Systems.Uses knowledge to improve Quality Systems, solve
problems, provide continuous improvement, and execute tasks.Provides compliance contribution to project teams and
leads small projects.Coaches and guides colleagues within the site.Responds to non-standard requests from customer needs.Makes decisions within guidelines and policies which
impact own priorities and allocation of time to meet deadlines.Supports Corporate Quality to ensure actions related to
Quality Systems at the site are executed.Participation in inspections of Site by Divisional /
Regulatory Bodies / third parties together with follow up actions where
applicable.Participate in GMP Walkthroughs.Deviation Management & Change Control approval.Ensures supply of high-quality product through the
implementation and oversight of the Quality Management System for the site.Champion the highest Quality and Compliance standards for
the site.Ensure highest safety standards.Additional activities as requested by QA Lead Required:Degree or 3rd level qualification (Science, Quality).Demonstrated knowledge in more than one pharmaceutical
and/or chemical manufacturing operation.5 years’ experience in the pharmaceutical industry or a
similar operating environment which includes experience in a Quality functionQuality Assurance SME knowledge, from both operational
and educational experience, is required.Knowledge and experience in interpreting current
regulatory requirements and providing independent support to the siteDemonstrated ability to work independently and fully
realize improvement initiatives with a moderate level of guidance.Demonstrated ability to work and succeed within teams as
well as leading small project teams.Demonstrated ability to drive the completion of tasks.Proven track record of providing independent Quality
support to the site.Advanced PC skills such as Excel, Word, PowerPoint.Stakeholder management of multiple decision makers,
auditors, cross functional teams by demonstrating the ability to maintain and
strengthen trust relationships with people on all levels.Proven decision-making capability with full
accountability and responsibility.Energetic with proactive & positive attitude.Demonstrated coaching skills.Demonstrated ability to solve problems.Shift Pattern: The role is a shift, full time onsite role providing
quality oversight to Operational.This role is integrated in the production
area. The shift is 5/2, week 1 is
M/T/F/S/S all 11-hour days. Week 2 is W/T 11.30 hr days.#LI-EL1