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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