Industry
Pharma/Biotech/Clinical Research
Location
City: Carlow
State/Province: Carlow
Country: Ireland
Job Description
About PSC Biotech
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 points 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 to working in top pharmaceutical client sites in a diverse cultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech; we provide empowering career development through Learning & Development, in-house training and mentorship to facilitate career progression.
We strive to create 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 met.
Overview
The Quality Assurance Specialist within our company is required to:
Technical knowledge of sterile manufacturing processes
Perform timely reviews of batch documentation / investigations / reports and assist in the resolution of concerns commensurate with the risk
Respond quickly to unplanned events, technical issues
Operational experience of quality systems in a dynamic manufacturing environment e.g., SAP, Trackwise, MES
Full understanding of relevant quality and compliance regulations; knowledge of requirements for cGMP, US and EU regulatory requirements
Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
Support the spot check/walk-through process of the production lines
Involved in customer complaint investigation if required
Requirements
Responsibilities
Provide Quality support to IPT production teams to ensure cGMP standards are maintained
Understanding of sterile manufacturing operations is preferred
Ability to learn and utilize computerized systems for daily performance of tasks
Ability to prioritize, manage multiple tasks, and meet deadlines
Perform timely reviews on batch documentation (EBRs) / line clearances / assist in the resolution of concerns commensurate with the risk.
Liaise with other Department representatives to promote improvements in GMP and Quality standards
Comply with current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations
Qualifications & Experience - Knowledge & Skills
Skills and Knowledge:
Typical Minimum Education
Bachelor's Degree or higher preferred in a Science discipline
Typical Minimum Experience:
1-2 years experience in a Quality Role at pharmaceutical manufacturing facility, preferably aseptic manufacturing
Technical:
Working knowledge of regulatory/code requirements for Irish, European and International Codes, Standards and Practices
Knowledge of cGMP and GDP; report and policy writing skills required
Competent in the use of MES and SAP
Shift Pattern
This is a shift position – 4 cycle 12 hours per shift
Week 2: short week – Wed and Thurs Days
Week 3: long week – Mon–Tue nights, Fri, Sat and Sun Days
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