Quality Assurance Specialist-Hybrid

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 Functions:

• Provide quality oversight and direction for the
  introduction of new equipment up to and including validation activities.
  
• Conduct quality reviews and approvals of engineering/
  commissioning and qualification activities.
  
• Conduct quality reviews and approvals of
  validation/automation/utilities activities.
  
• Support deviation Investigations and close out in a
  timely manner.
  
• Quality oversite of Change controls related to
  introduction, commissioning and qualification of new equipment.
  
• Quality oversite of Quality Risk assessments related to
  introduction, commissioning and qualification of new equipment.
  
• Facilitate compliance direction for the site by adhering
  to divisional policies, guidelines, and regulatory requirements. Proactively
  evaluate site compliance against emerging trends and initiate major compliance
  initiatives for improved status and operational efficiency. Actively
  participate in Plant/Quality committees and collaborate with other site
  functional groups.
  

Requirements

Experience, Knowledge & Skills:

• A minimum of 3-5 years of experience in a quality role,
  ideally in a pharmaceutical manufacturing environment.
  
• A bachelor’s degree or higher in a related Science
  discipline is preferred.
  
• A minimum of 3 years of experience in a quality role,
  ideally in a pharmaceutical manufacturing environment.
  
• Knowledge of regulatory/code requirements related to
  Irish, European, and International Codes, Standards, and Practices.
  
• Familiarity with cGMP (current Good Manufacturing
  Practice) and GDP (Good Distribution Practice) is preferred.
  
• Strong Continuous Improvement Mindset.
  
• Strong report, standards, and policy writing skills.
  
• Experience with equipment and process validation.
  
• Familiarity with sterile filling processes and equipment.
  
• Proficiency in Microsoft Office and job-related computer
  applications.
  
• Experience or familiarity with Lean Six Sigma methodology
  is desired.
  
• Good collaboration skills and the ability to work
  effectively as part of a team to determine priorities.
  
• Demonstrated ability to work independently and take
  ownership of improvement initiatives with a moderate level of guidance.
  
• Proven ability to drive the completion of tasks.
  
• Strong decision-making capability with a sense of
  accountability and responsibility.
  
• Demonstrated problem-solving skills.
  

Qualifications & Education:

• A Bachelor's degree or higher in a related Science
  discipline is preferred.
  

• 11 Month of Contract