Quality Assurance Specialist-Shift, Carlow

Industry Pharma/Biotech/Clinical Research City Carlow State/Province Carlow Country Ireland Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the“heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning&Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

The Quality Assurance Specialist within Our Company isrequired 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 concernscommensurate with the risk

Respond quickly to unplanned events, technical issues

Operational experience of quality systems in a dynamicmanufacturing environment eg SAP, Trackwise, MES

Full understanding of relevant quality and complianceregulations knowledge of requirements for cGMP, US and EU regulatoryrequirements

Conduct, report and display of Quality right first time,audit readiness metrics weekly to ensure continuous audit readiness and cGMPcompliance

Support the spot check/walk-through process of theproduction 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 ensurecGMP standards are maintained.

Understanding of sterile manufacturing operations ispreferred.

Ability to learn and utilize computerized systems fordaily performance of tasks.

Ability to prioritize, manage multiple tasks, and meetdeadlines.

Perform timely reviews on batch documentation ( EBR’s ) /line clearances/ assist in the resolution of concerns commensurate with therisk. Liaise with other Department representatives to promote improvements inGMP and Quality standards

Comply with our current Manufacturing Division, Qualityand EHS Management System requirements, as relevant to commercial operations.

ReportingStructure:Reports to Quality Manager

Qualification , Education and Skills

Skills and Knowledge

Typical Minimum Education

Bachelor’s Degree or higher preferred in a Sciencediscipline

Typical Minimum Experience

1-2 years experience in a Quality Role at pharmaceuticalmanufacturing facility preferably aseptic manufacturing

Technical

Working knowledge of regulatory/code requirements toIrish, 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 notapplicable for this role,

This is a shift position– 4 cycle - 12 hours per shifte.g

Week 2- short week: Wed and Thurs Days,

Week 3:Long week: Monday– Tuesday nights, Friday, Satand Sun Days

Week 4: short week: Wednesday and Thurs Nights

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

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