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:The Quality Systems Compliance Specialist is responsible
for maintaining and continuous improvement of our Quality Management System
throughout their knowledge and areas of expertise. Ensure that objectives are
effectively achieved, consistent with our requirements to ensure compliance,
safety and reliable supply to our customers.RequirementsResponsibilities:Provide quality support to the project and site,
including training and guidance on the interpretation and implementation of our
Guidelines / Policies and regulatory requirements.The main areas of expertise are, but not limited to,
specific tasks and roles such as: deviation management, change control
management, quality systems management, document / SOP management, data
integrity management, GMP training & knowledge management.Ensure the health & well-being of the Quality
Management system at the site to ensure timely actions are taken to meet
compliance & production needs.Serve as support for metrics management for site
deviation management and change control systems.Support the review and approval of site deviation and
investigations reports.Support maintenance of the site master file and site
manufacturing license and variations, as required.Ensure root causes have been identified and corrective
action implemented and can demonstrate basic knowledge of six sigma, LEAN, and
root cause analysis tools used for identifying and correcting deviations.Day to day management of Deviation, CAPA and Change
Control, QRM metrics.Support the oversight of the quarterly deviation trending
process (by cross functional area owners) on a routine basis and responsible
for the completion of annual trending at Site.Liaise directly with cross-functional departments to
ensure that change control and deviation management system requirements are
met.Support Regulatory and Compliance Inspections at the
site, as required.Support for management of recalls, as required.Comply with our Global and regulatory requirements and
execute current Good Manufacturing Practices (cGMP) in the performance of
day-to-day activities and all applicable job functions.Build a Quality culture that delivers unconstrained
supply, Right First Time to our patients.Support Quality Risk Management process Skills Required:Over 4 years’ experience in Quality Control, Quality
Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical
Operations.Motivated to be an inspiring member of a high performing
team.Excellent interpersonal skills: communication, decision
making, people influencing skills.Ability to interact with multiple stakeholders.Desire to continuously learn, improve and develop.Excellent knowledge of relevant Quality and Compliance
Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements,
Regulatory Affairs, Training) and respective regulations.Experience with new product introductions and/or process
qualification/technology transfer.Bachelor’s degree (or higher) in Chemistry, Biology,
Microbiology, Automation, Engineering, or equivalent. #LI-EL1