Technical Writer

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 Biologics Centre of Excellence Technical Writer
  supports Biologics CoE operations through effective document management and
  training administration. This role requires strong technical writing expertise
  with training coordination, thereby ensuring regulatory compliance, inspection
  readiness, and support personnel cross-training. The role requires demonstrated
  skills for initiative, self-motivation, outstanding organisational skills, and
  a proven ability to work independently.
  
• 12 Month of Contract with possibility of an extension
  

Requirements

Key Responsibilities

• Lead, develop, and drive the ongoing enhancement of the
  documentation management strategy
  
• Produce high-quality, accurate documentation by applying
  data integrity and ALCOA principles, adhering to compliance best practices, and
  ensuring all materials are appropriate for their intended audience
  
• Serve as Subject Matter Expert (SME) for Veeva Quality
  Documents & Compliance Wire, offering guidance and support to colleagues in
  the use of these systems
  
• Draft, review, and approve BPDs, SOPs, technical
  protocols & reports, forms, work instructions, and other document types
  
• Collaborate closely with technical SMEs and teams to gain
  deep business and product knowledge for accurate documentation requirements
  
• Demonstrate excellent verbal and written communication
  skills to engage and motivate diverse audiences
  
• Propose and implement continuous improvements to the
  technical writing process, such as developing Advanced Templates
  
• Support Technical Writing activities across the site and
  collaborate with various departmental SMEs
  
• Manage the transition of documentation into Veeva Quality
  Documents and initiate Change Requests as necessary
  
• Support Global Training &/or Bus Ops with BcoE
  training development programs and materials, guides, and e-learning modules to
  address identified learning requirements
  

Education and Experience (required):

• Third level qualification in a Science or an Engineering
  discipline, and/or extensive related proven experience in the required areas:
  technical document writing
  
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