Quality Assurance 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.

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:

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
  

Requirements

Responsibilities:

• 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

Qualification , Education and Skills

Skills and Knowledge

Typical Minimum Education

• Bachelor’s Degree or higher preferred in a Science
  discipline
  
• Typical Minimum Experience
  
• 1 -2 years experience in a Quality Role at pharmaceutical
  manufacturing facility preferably aseptic manufacturing
  
• Experience in SAP, MES, Trackwise desirable
  

Technical

• 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 and remote or hybrid is not
applicable for this role,

• This is a shift position – 4 cycle - 12 hours per shift
  e.g
  
• 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: Wednesday and Thurs Nights  
  
• For the job shift experience, working in a quality
  function or in an aseptic environment is beneficial