QA Systems & Compliance

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 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.

Overview

• This position reports to the Associate Director, External
• Quality, Quality Systems & Compliance.The main responsibility of this role is supporting the Quality Systems
• program within External Quality ensuring key Quality System elements such as
• Oversight, Deviations, CAPA’s, and Change Controls are consistently
• administered and in compliance with relevant Regulatory Standards
• This is a 12 Month of contract role

Requirements

• Key Responsibilities for this Role as follows;
• Perform the Quality Systems Metric Review for GEO and
• oversee relevant metrics and trending for each quality system within GEO to
• proactively drive on-time closure of Quality records.
• Support development and implementation of digital
• improvement initiatives for External Quality.
• Responsible for managing routine cross-functional
• meetings to ensure timely closure of Deviations, CAPAs and Change Control, with
• leadership endorsement.
• Responsible for development/reporting of metrics and
• supporting standardization of these across the Organization.
• Co-ordinate monthly governance site quality review team
• (SQRT) meeting for GEO.
• Deliver training on Quality Management Systems within
• GEO, as required.
• Partner with the Global Quality Systems Management Team
• and other cross functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives
• to the External Quality systems.
• Participate in the change control program for
• modifications to qualified systems (within GEO).
• Assist as needed in audits and inspections.
• Participate in development and implementation of global
• alignment projects with sites.
• Support the Self Inspection Programme for External

Quality

Other duties as assigned

The ideal candidate will have the following experience

/ skills

• Bachelor’s Degree in science or engineering
• Minimum 1+ years of biopharmaceutical experience in a
• Quality, Compliance, and/or Regulatory setting
• Skilled in data analysis and excel. Power bi and AI
• tool’s experience desirable.
• Strong communication and interpersonal skills – Oral,
• written and presentation skills
• Works collaboratively with others to meet shared
• objectives.