Qualified Person

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.

Overview:

This role will be part of our Quality Assurance Team in our state of the art single use multi-product biotech facility in Ireland.

Requirements

Role Functions:

• An exciting opportunity has arisen for an experienced Qualified Person to join our Quality department at our Biologics facility
  
• Our facility is a premier state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic activity-based workspace the facility will support seamless connection and collaboration within and across teams and functions.
  

Responsibilities:

• Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
  
• Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization product
  
• specification file legal obligations and/or technical agreement. Manage and/or escalate any potential CGMP and/or other concerns in a timely manner.
  
• Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture testing and those that may present potential effect on product and /or material.
  
• Confirm change requests with product impact which require expanded review (e.g. regulatory stability testing impact) have been appropriately reviewed approved and technically closed.
  

Experience Knowledge & Skills:

• EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
  
• Expert level of knowledge of relevant GMPs regulations and current industry trends.
  
• Communication decision making people influencing and project management skills. Problem-solving / critical thinking ability to understand connections between different technical/quality system areas and recognize potential compliance issues.
  

Qualifications & Education:

• EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures.
  
• BSc. degree (or higher) in Biotechnology Chemistry Biology or in a relevant discipline.