QA Specialist - Senior

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.

Overview:

Organizes, manages, and controls Project Readiness activities relating to large retrofits and new line introductions. Leads the Project Readiness cross -functional team and manages the development, roll -out, and implementation of all aspects of Project Readiness for large retrofits/new line introductions. Responsible for facilitating and developing cross functional Project Readiness plans, timelines, and resource requirements to ensure successful project delivery including FPO’s

Duties and Responsibilities

• Review
  Batch Records and material release (including CoA) to ensure compliance
  with GMP requirements.
  
• Quality
  review and approval of Master Batch Records (MBR) for routine cleaning and
  process activities, including automation recipe updates.
  
• QA
  review and approval of SOPs, Work Instructions, and forms from other
  departments.
  
• Attend
  daily/weekly Operations -led team meetings.
  
• Conduct
  Gemba walkdowns and Inspection Readiness walkdowns from a QA perspective.
  
• QA
  review and approval of Warehouse Shipping Picklists.
  
• Act
  as the primary QA point of contact for Quarantine Shipments.
  
• Responsible
  for Batch Book filing and archival.
  
• QA
  review and approval of quality non -conformance (NC) records and customer
  complaint non -conformance records.
  
• Initiate
  and own QA non -conformance records.
  
• Perform
  periodic reviews of Quality Assurance and Quality Systems SOPs.
  
• Act
  as the primary Quality representative at Root Cause Analysis meetings.
  
• Serve
  as the primary QA point of contact for the Returns process.
  

Minimum Requirements

Key Skills and Competencies

• Builds
  strong, productive relationships.
  
• Demonstrates
  the ability to work effectively with teams and individuals.
  
• Seeks
  opportunities for professional growth and development.
  
• Utilises
  best practices to improve business operations.
  
• Holds
  themselves accountable for compliant and flawless execution.
  
• Takes
  responsibility for decisions that build customer value.
  
• Effectively
  manages and adapts to change.
  
• Always
  demonstrates integrity and Credo -based actions.
  
• Able
  to work independently, manage time effectively, and meet deadlines.
  

Requirements

Education and Experience

• Third -level
  degree in a science or pharmaceutical discipline.
  
• Minimum
  of 3 -5 years’ experience in the pharmaceutical industry.
  
• Working
  knowledge of quality processes and systems is desirable.
  
• Demonstrated
  knowledge and application of industry regulations, including FDA, HPRA,
  EMEA and other authorities.