Industry Pharma/Biotech/Clinical Research
Work Experience 1-3 years
City Carlow
State/Province Carlow
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in ****, 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.
The Quality AssuranceSpecialist 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 commensuratewith 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 compliance regulationsknowledge of requirements for cGMP, US and EU regulatory requirements
Conduct, report and display of Quality right first time, auditreadiness metrics weekly to ensure continuous audit readiness and cGMPcompliance
Support the spot check/walk-through process of the production lines
Involved in customer complaint investigation if required
Work well crossfunctionally and be an active team member
Provide Qualitysupport to IPT production teams to ensure cGMP standards are maintained
Understanding ofsterile manufacturing operations is preferred.
Ability to learn andutilize computerized systems for daily performance of tasks.
Ability to prioritize,manage multiple tasks, and meet deadlines.
Perform timely reviewson batch documentation ( EBR's ) / line clearances/ assist in the resolution ofconcerns commensurate with the risk.
Liaise with other Departmentrepresentatives to promote improvements in GMP and Quality standards
Comply with ourcurrent Manufacturing Division, Quality and EHS Management System requirements,as relevant to commercial operations.
REPORTING STRUCTURE
Reports to QualityManager
Requirements
QUALIFICATIONS& EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
Skills andKnowledge
Typical MinimumEducation
Bachelor's Degree or higher preferred in a Science discipline
Typical MinimumExperience
1-2 years experience in a Quality Role at pharmaceutical manufacturing
facility preferably aseptic manufacturing
Technical
Working knowledge of regulatory/code requirements to Irish, European andInternational Codes, Standards and Practices
Knowledge of cGMP and GDP essential Report, standards, policy writing skillsrequired
Competent in the use of MES and SAP
The position is onsite role
This is a shiftposition – 4 cycle 12 hours per shift e.g
Week 2- short week: Wed and Thurs Days,
Week 3:Long week: Monday – Tuesday nights, Friday, Sat and Sun Days
Week 4: short week: Wednes and Thurs Nights
Shift premium is 33%
For the job shiftexperience, working in a quality function or in an aseptic environment isbeneficial
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