QA Specialist Shift

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.

The Quality Assurance
Specialist within Our Company is required to

• Work a 4 shift pattern role
  
• Technical knowledge of sterile manufacturing processes
  
• Perform timely reviews of batch documentation / investigations /
  reports highlighting and assist in the resolution of concerns commensurate
  with the risk
  
• Respond quickly to unplanned events, technical issues
  
• Operational experience of quality systems in a dynamic
  manufacturing environment eg SAP, Trackwise, MES
  
• Full understanding of relevant quality and compliance regulations
  knowledge of requirements for cGMP, US and EU regulatory requirements
  
• Conduct, report and display of Quality right first time, audit
  readiness metrics weekly to ensure continuous audit readiness and cGMP
  compliance
  
• Support the spot check/walk -through process of the production lines
  
• Involved in customer complaint investigation if required
  
• Work well cross
  functionally and be an active team member
  
• Provide Quality
  support to IPT production teams to ensure cGMP standards are maintained
  
• Understanding of
  sterile manufacturing operations is preferred.
  
• Ability to learn and
  utilize computerized systems for daily performance of tasks.
  
• Ability to prioritize,
  manage multiple tasks, and meet deadlines.
  
• Perform timely reviews
  on batch documentation ( EBR’s ) / line clearances/ assist in the resolution of
  concerns commensurate with the risk. Liaise with other Department
  representatives to promote improvements in GMP and Quality standards
  
• Comply with our
  current Manufacturing Division, Quality and EHS Management System requirements,
  as relevant to commercial operations.
  

REPORTING STRUCTURE

Reports to Quality
Manager

Requirements

QUALIFICATIONS
& EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

Skills and
Knowledge

Typical Minimum
Education

• Bachelor’s Degree or higher preferred in a Science discipline
  

• 1 -2 years experience in a Quality Role at pharmaceutical manufacturing
  facility preferably aseptic manufacturing
• Experience in SAP, MES, Trackwise desirable
  

• Working knowledge of regulatory/code requirements to Irish, European and
  International Codes, Standards and Practices
  
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills
  required
  
• Competent in the use of MES and SAP
  
  

The position is onsite role

• Week 1 - long week: Monday – Tuesday Days, Friday, Sat, Sun nights
  
• Week 2 - short week: Wed and Thurs Days,
  
• Week 3:Long week: Monday – Tuesday nights, Friday, Sat and Sun Days
  
• Week 4: short week: Wednes and Thurs Nights   
  

Shift premium is 33%

For the job shift
experience, working in a quality function or in an aseptic environment is
beneficial