Quality Control Technician

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.

Technician, Quality Control

• Comply with and execute CGMP/GDP in the performance of
  day-to-day business activities.
  
• Ensure data integrity principles: Attributable, Legible,
  Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and
  data in day-to-day business activities.
  
• Attend and successfully complete applicable CGMP
  training.
  
• Escalate any potential violation of CGMP and/or other
  concerns which may affect the safety, efficacy, quality, or purity of  human health products.
  
• Work collaboratively to ensure a safe and compliant
  culture
  
• Participate in driving a high performing s inclusive
  culture, stimulating personal growth s development may be required to perform
  other duties as assigned.
  
• Coordinate the end-to-end sample lifecycle in GLIMS:
  receipt, logging, processing, distribution and traceability through to
  disposal.
  
• Prioritise and schedule sample workload to meet timelines
  
• Coordinate shipment of samples to external contract
  laboratories and sister sites
  
• Log retain samples in accordance with retain sample
  management programme
  
• Ensure day-to-day activities meet GMP and regulatory
  standards
  
• Contribute to root cause investigations using structured
  problem-solving tools
  
• Identify and deliver continuous improvement projects that
  improve efficiency and reliability
  
• Partner with Manufacturing, QC, Quality Assurance,
  External Quality and other stakeholders to meet site goals
  

Requirements

About You:

• Experience with a LIMS (GLIMS experience is an advantage)
  
• Strong communicator, comfortable working with
  stakeholders at all levels
  
• Able to prioritise and deliver against competing
  deadlines
  
• Collaborative and able to communicate effectively across
  functions
  
• Committed to continuous improvement and operational
  excellence
  

Responsible for activities including some or all of
the following and any other tasks as required:

Quality:

• Liaise with the QC Leads to resolve quality related
  queries where required
  
• Ensure that adequate processes and procedures are in
  place and followed for all Quality activities.
  
• Provide support to the relevant support functions to
  ensure manufacturing and release
  
• activities, in compliance with applicable procedures, our
  Company’s Global Policies and Guidelines, regulatory requirements and current
  Good Manufacturing Practices (cGMP).
  
• Develop and maintain effective cross-functional
  relationships with other departments and support functions to ensure that the
  process for the manufacturing, testing and release of vaccine and biologic
  products are in compliance with cGMP and the associated regulatory
  requirements.
  
• Identify and support compliance initiatives to improve
  compliance status and overall operational efficiency for batch release at the
  site.
  
• Support business critical projects related to the Quality
  Department.
  

Delivery:

• Responds to standard requests and communication processes
  to allow the flow of appropriate information between departments.
  
• Use MPS principles and tools to identify and support
  continuous improvement by active participation to ensure quality systems and
  work practices are effective, efficient and ensure compliance and overall
  operational efficiency for batch and material release at the site where
  required.
  
• Sign approved job description.
  

Site Business Area Support:

• Support in resolving routine potential quality issues.
  
• Provide quality support of controls and procedures for
  the end to end material and product lifecycle where applicable.
  
• Assist team members to support the
  qualification/validation, technical transfers, and commercial operations at the
  facility where required.
  

Quality Control:

• Support the Sample Management team members completing day
  to day activities, as applicable.
  

Compliance Responsibilities:

• Ensure compliance to regulatory requirements.
  
• Assist team members with tasks relating to SOP's,
  Deviations and other documents as necessary for the Quality and Manufacturing
  departments where required.
  
• Contribute to effective writing/revising/rolling out of
  accurate operational procedures, training materials and maintenance procedures
  for various Quality related systems.
  

Other:

• Participate in training programs as required.
  

Typical Minimum Education:

• Leaving Certificate or other relevant experience.