QA Digital Manufacturing Lead

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.

Summary:

The QA Digital Manufacturing Lead provides Quality
Assurance oversight and guidance for the implementation of digital
manufacturing solutions within a pharma manufacturing environment. The role
focuses on enabling review by exception (RBE), electronic batch records (eBR),
and paperless operations, ensuring compliance with GMP, data integrity, and
regulatory expectations while supporting operational efficiency.

Requirements

Essential Duties and Responsibilities include, but are
not limited to, the following:

• Provide QA leadership and guidance for the design and
  implementation of eBR and paperless manufacturing processes.
  
• Define and approve review by exception (RBE) strategies,
  including deviation thresholds, exception handling, and QA review models.
  
• Ensure digital manufacturing solutions are aligned with
  GMP, data integrity principles (ALCOA+), and applicable regulatory requirements
  (e.g., FDA, EU).
  
• Partner with Manufacturing, Automation, IT, and Quality
  teams to embed quality -by -design into digital workflows.
  
• Review and approve quality requirements, risk
  assessments, and validation/CSA deliverables related to digital plant systems.
  
• Support inspection readiness by ensuring digital
  processes are defensible, well -governed, and clearly documented.
  

Education and Experience:

• Strong QA background in pharmaceutical manufacturing
  under GMP.
  
• Hands -on experience with eBR, DeltaV, MES, or digital
  manufacturing systems.
  
• Solid understanding of review by exception concepts and
  paperless batch release.
  
• Ability to balance compliance, risk -based thinking, and
  operational efficiency.