QA Senior Associate

Who we are

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.

Job Overview:

• The Senior Associate for Plant Quality Assurance (PQA) will report to the QA Manager playing a pivotal role in the sites Quality Assurance team. As the Quality point of contact for manufacturing and inspection operations the PQA Senior Associate will contribute to continuous improvement initiatives by undertaking additional responsibilities beyond routine QA duties.
  
• This 24/7 shift role demands a 12hour shift pattern (4 on 4 off) to support manufacturing operations.
  

Requirements

Key Qualifications & Experience:

• Exceptional written and verbal communication skills.
  
• Proven experience collaborating with dynamic crossfunctional teams and strong decisionmaking abilities.
  
• Robust organizational skills with a commitment to seeing assignments through to completion.
  
• Demonstrated problemsolving abilities particularly in supporting nonconformance/deviation investigations.
  
• Experience in inspecting vials and syringes and engaging in aseptic operations.
  
• Familiarity with applicable Regulatory requirements and proficiency in evaluating compliance issues.
  

Key Responsibilities:

• Ensure adherence to safety standards and SOPs in all activities.
  
• Review and approve production batch records and associated documentation for Qualified Person disposition activities.
  
• Provide realtime quality oversight and support for production unit operations extending to formulation vial and syringe Fill Finish activities including media fills and assessment of aseptic interventions.
  
• Conduct inspections of vials and syringes as part of AQLs annual reserve inspections and support complaint investigations.
  
• Offer Quality Assurance support for onthefloor investigations and deviations.
  
• Review and approve deviations for closure ensuring compliance with appropriate documentation.
  
• Participate in customer complaint investigations.
  
• Conduct routine Quality Assurance walks on the production floor.
  
• Review and issue logbooks ensuring compliance with procedures.
  
• Provide training and guidance to staff for effective performance.
  
• Review and approve cGMP records ensuring compliance with appropriate documentation.
  
• Support continuous improvement and Operational Excellence initiatives.
  
• Undertake other tasks/projects as assigned by the manager.
  

Basic Qualifications & Experience:

• University degree in an Engineering or Sciencerelated discipline (preferred).
  
• Over 4 years of relevant experience in the pharmaceutical or biotechnology industry or an equivalent combination of experience and educational background.