Quality Assurance Specialist

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

Role Description:

The Contractor is a member of a team within Global Development Quality (GDQ) and is involved in supporting the GMP Quality Assurance activities for the GDQ IMP Licence at the  site.

Requirements

Role Functions

• Completes audits of data, information, procedures, facilities, equipment and systems (inc computer systems) to ensure compliance to SOPs, GMPs and applicable regulations.
  
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
  
• Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilise this network to help resolve comments and issues that arise during audit and review.
  
• Support product recalls and stock recoveries as appropriate.
  
• Identify compliance gaps and make recommendations for continuous improvement
  
• Creates and maintains assigned SOPs.
  
• Perform and review complaints and deviation investigations, change controls and CAPA’s.
  
• May assist in the induction process for new starters.
  
• Generally follows standard procedures and consults with manager/supervisor on exceptions.
  
• Compiles data for reports and presentations - May interpret data and draw conclusions.
  
• Carries out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
  
• Keep abreast of cGMP requirements as described in applicable worldwide regulations.
  
• Additional activities may be assigned by the manager/supervisor
  

Experience, Knowledge & Skills:

• The contractor is required to possess a degree in an Engineering or Science discipline.
  
• Alternatively, they must possess significant industrial experience.
  

Qualifications & Education

• The contractor is required to possess a degree in an Engineering or Science discipline.
  
• Alternatively, they must possess significant industrial experience.