QA 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
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

Role Functions:

• Supplier Management oversight
  
• Quality Agreement management & APR Quality Agreement
  Chapter owner
  
• Review documentation associated with new product and
  material introduction, such as Material Packs, QC Test Specifications, BOMs,
  Supplier Qualification and Oversight.
  
• Develop and monitor supplier performance metrics,
  participate in material review boards and quarterly reviews of key suppliers,
  and actively engage in cross-functional forums as needed.
  
• Maintain the approved supplier management list within the
  qualified Supplier Management system, ensuring correct setup of suppliers and
  materials used .
  
• Support deviation and atypical closeout, as well as
  initiate and follow up on corrective and preventive actions.
  
• Support change controls & Supplier Complaints.
  
• Provide quality oversight and direction for the
  introduction of new products and materials, as well as manage external parties
  including periodic re-evaluations.
  
• Author, review, and approve protocols and reports for
  technology transfer, method qualification, and method validation.
  
• 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.
  
• Participate as a functional expert in the
  cross-functional team responsible for introducing products and materials .
  

Requirements

Experience, Knowledge & Skills:

• A minimum of 3-5 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 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.
  

Additional Notes:

• Hybrid, usually 2/3 days per week on site
  
• Day role
  
• 11 Month Contract
  
• Application Deadline: 12th Oct