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.

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.