Technical Writer

2 weeks ago

Limerick, Ireland PSC Biotech Ltd Full time

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.

Technical Writer - Cleaning Validation SIP

An experienced Technical Writer is required to become a key member of the Cleaning Validation team within a renowned Limerick based Biotech multinational. This is an excellent opportunity to develop your career while working in a dynamic state of the art facility.



Requirements

Responsibilities:

  • Experienced Technical writer
  • Experience in Deviation and investigation 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.
  • Maintain and update Cleaning/ SIP Validation Plan
  • Schedule of Cleaning/ SIP activities with Manufacturing

 

Qualifications and Experience:

  • Bachelors Degree in Science or Engineering
  • Experienced 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 white papers and site reports.
  • Technical writing experience for continuing assessments

 

Skills:

  • Cleaning Validation SIP cip Technical Writing

 

 



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