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.