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