Qualified Person Clinical Supplies

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:

• An amazing opportunity has arisen for a temporary contract position of a Clinical Supplies Qualified Person supporting the Global Development Quality Team that supports expanding Clinical Trials programs in Europe. We are looking to recruit a Qualified Person (QP) to be named on the site licence supporting the release of clinical trials supplies.
  
• This is a 12 month role reporting to the Senior Director of Quality Assurance.
  

Requirements

Responsibilities:

• Bring energy knowledge innovation and leadership to carry out the following:
  
• The QP will be involved in the review and certification of batches intended for use in clinical trials to ensure compliance with EU GMP the Product Specification File and the Clinical Trial Application.
  
• This role will encompass product manufactured across the company Global Supply Chain and subsequently imported into the EU. Products include Small Molecules Large Molecules Biologics Vaccines Gene Therapy etc
  
• The QP will be involved with Health Authority Inspections to maintain the site licences audits both internal and external.
  
• This role will also be involved in ongoing compliance activities related to clinical trials for example technical and quality agreements with collaborators stock recovery activities etc.
  

Skills & Qualifications:

• Eligible to be named as a Qualified Person (QP) and to have maintained CPD.
  
• Practical experience with disposition of product types such as Sterile Nonsterile Biologics Vaccine Gene Therapy or ATMP is preferable. Including at least two year s experience in quality assurance or qualitative analysis of related medicinal products. Familiarity with EudraLex Chapter 4 Annex 13 Annex 16 and applicable EU CTR regulations 536/2014.
  
• A recognised pharmacy degree course at a third level institution in Ireland or if the pharmacy course has been completed outside of Ireland evidence of Pharmaceutical Society of Ireland registration and acknowledgement from the EU competent authority where the pharmacy degree was completed to meet the educational requirements of Article 49 of EU Directive 2001/83/EC and Article 97 of the EU Regulation 2019/6.
  
• An academic qualification at least equivalent to a level 8 primary course in a scientific discipline and has successfully completed a recognised post-graduate course in Ireland that satisfies the educational requirements as defined in the EU Regulation 2019/6 and the EU Directive 2001/83/EC.
  
• Extensive experience in a cGMP environment preferably gained in a Quality function with respect to clinical trials/IMP environment.
  
• Experience with conducting audits and hosting inspections.
  
• Dynamic individual with excellent organizational skills who can work effectively and proactively on global functional teams.
  
• Effective verbal and written communication skills in collaborating to colleagues and associates both inside and outside the organisation.