QC Doent Controller

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.

Overview:

• Responsible for supporting the Quality Control Department in the management of laboratory GMP doentation and in supporting the various administrative duties. Ensuring that objectives are effectively achieved to consistent with client s requirements to ensure Compliance safety and reliable supply to our customers.
  
• This is a day role MonFriday based on site.
  

Requirements

Role Functions:

• Be a doent system expert for the Quality Control Department; this will include doent generation and review and doent system workflow expedition where applicable examples include Standard Operation Procedures Work Instruction Policies Safety procedures Annual Product Reviews electronic logs.
  
• Format write and deliver necessary doentation in line with client s Global Policies Procedures and Guidelines regulatory requirements.
  
• Support laboratory administration activities through doentation generation doentation filing tracking and auditing.
  
• Manage and complete department specific ignments including periodic review of doents.
  
• Support continuous improvement by active participation and engagement with laboratory team for doent updates out of investigations and corrective actions.
  
• Contribution to Kaizen events and doentation improvement projects as appropriate.
  
• Ensure timely completion of all igned doents to meet site metric requirements.
  
• Work collaboratively to drive a safe and compliant culture
  
• Participate in QC daily meetings and ensure effective communication of igned tasks/projects etc.
  
• May be required to perform other duties as igned.
  
  

Experience Knowledge & Ss

Technical:

• Proficiency in Microsoft word Office excel and electronic data management systems
  
• Knowledge of regulatory/code requirements to Irish European and International Codes Standards and Practices
  
• Report standards policy writing ss required
  
• Understanding of Lean Six Sigma odology preferred
  

Business:

• Excellent communication presentation and interpersonal ss to interface effectively with all levels of colleagues and with external customers in a team orientated manner
  
• Ability to work with teams and escalate issues to management in a proactive manner
  
• Customer service
  
• Goal/results orientated
  
• Training ss
  
• Effective time management and multitasking ss
  
• Proven organizational ss
  
• Excellent attention to detail
  
• Selfmotivated
  
• Flexible approach
  
• Planning and scheduling ss
  

Qualifications & Education

• Typical Minimum Education:
  
• Degree preferred; ideally in a related discipline
  

Typical Minimum Experience:

• Experience and/or a particular s set in their area of expertise that adds value to the Business preferably GMP setting.