Technical Writer - Cleaning Validation

Who we are?

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.

• Experienced Technical writer,
  
• Experience in Deviation and investigaton writing,
  
• Experience in Validation specifically CIP/SIP and continuing validation
  
• Experience in assessment of CIP/SIP issues during study runs and closeout of deviations
  
• Experience in KAYE validator reporting review beneficial
  
• Capable of managing a large program, so project management skills would be necessary,
  
• An understanding of how manufacturing, CIP and SIP Validation equipment works
  
• Generate/review/Approval of SIP protocols
  
• Generation of Summary Reports and strong quality background essential
  
• Experience in continuing validation and generation of assessments for continuing
  
• Assessment of impact of issues/ deviations which arise through the assessment generation.
  
• Ability to work on own initiative
  
• Maintain and update Cleaning/ SIP Validation Plan
  
• Schedule of Cleaning/ SIP activities with Manufacturing
  
• Liaise with numerous departments
  
• Shows focus & a consistence approach to the role and tasks.
  
• Excellent people skills
  
• Ensure Training is maintained and current.
  
• Follow all EHS/Safety SOP/Policies
  
• Actively look for Continuous improvements
  

Requirements

• Experenced in QA Validation activities
  
• Execution, review & approval of SIP/ CIP and continuing validation protocols and closure
  
• Extensive experience on writing and approving Deviations
  
• Technical writing experience has written a number of whit