IT Compliance yst 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 cloudbased 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 likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 IT Compliance Analyst is responsible for ensuring that the IOPS IT group is operating in compliance with Regulatory requirements and internal procedures as well being the key liaison between the IT and Quality Assurance groups.

Requirements

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

• Provides Technical Writing assistance with the creation/updating of Documents.
  
• Provides Technical Writing assistance with the management of Change Controls Deviations CAPAs.
  
• Provides Technical Writing assistance with the completion of System Periodic Reviews.
  
• Supports the of System Audit Trail Reviews.
  
• Tracks and reports on IOPS IT Quality Metrics.
  
• Champions Data Integrity for all IT systems
  
• Represents IOPS IT at various site/crosssite meetings.
  
• Ensures IOPS IT procedures follow regulatory and corporate requirements.
  
• Ensures IOPS IT personnel are operating in compliance with regulations and procedures.
  
• Help ensure the training provided to IOPS IT Training personnel is adequate.
  
• Represents IOPS IT or assists IOPS IT SME s during in internal and external audits.
  
• Ensures IT Operational Controls are in place and maintained throughout the system lifecycle e.g. Periodic Reviews Disaster Recovery testing Performance Monitoring etc.
  

• BS/BA in related field and a minimum of 2 years relevant experience preferred; will substitute relevant industry experience for educational requirement.
  
• Excellent people and communication skills
  
• Troubleshooting and analytical mindset
  

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