Senior Quality Assurance Associate

1 month ago

Dublin, Ireland PSC Biotech Ltd Full time
About PSC Biotech

 

 

Who we are?

 

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 Plant Quality Assurance (QA) Senior Associate will report to a Senior QA Manager and is a core member of the site QA team.
  • The QA Senior Associate will act as Quality point of contact for manufacturing operations and is responsible for oversight of:
  • Medical Device assembly
  • Serialized Packaging and labelling.


Requirements

Skills required:

  • Strong attention to detail in terms of task execution and QA review.
  • Proven in Risk Based Decision Making – ability to assess both the impact of an event that occurs and the suggested path-forward.
  • Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels with the organisation.
  • Strong organizational skills, including ability to follow assignments through to completion – ability to work well on own and as part of a dynamic team.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
  • Operational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements.
  • Problem solver
  • Advising and finding a complaint path forward
  • Previous Production experience
  • Ability to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of ant change to cycle)

 

Team Responsibilities:

Purposeful Presence on the floor:

  • Triage
  • PPOF
  • Defect Classification
  • Pack Checks
  • Audit Walks
  • QA Lock outs

 

Quality Review:

  • Logbooks
  • GMP Documentation
  • Batch Records
  • Deviations
  • Protocols

 

Role Responsibilities:

  • Perform all activities in compliance with client safety standards and standard operating procedures.
  • Observe and provide real-time quality oversight and support for manufacturing on the floor.
  • Perform purposeful presence on the floor audits.
  • Perform manual pack check and deft assessment
  • Perform Batch Review to support customer complaint investigations
  • Provide quality support for triage and investigation of all classes of deviation events.
  • Review/approve deviations for closure ensuring compliance with appropriate standards.
  • Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Write, review and approve standard operating procedures in accordance with client policies.
  • Support continuous improvement and operational excellence initiatives
  • Any other tasks/projects assigned as per manager’s request.


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