QA Validation Ireland

Location: San Lorenzo Tenochtitlán

About PSC Biotech

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.

‘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.

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.

Accountable to provide quality oversight to validation and equipment qualification activities to ensure these activities are compliant with all applicable regulations, company and contractual obligations.
Accountable for review and approval of commissioning and qualification activities, including the pre and post-execution review & approval of all validation lifecycle documents.
URS, FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications, 21 CFR Part 11 assessment, Data Integrity Assessment, Configuration Specifications, Design specifications.
Participate or lead investigation, where possible related to discrepancies identified during qualification activities
Review & approve SOPs, Deviations/Event, CAPAs, Change Controls, Periodic Maintenance plans and user access request’s etc..
Align with company’s Quality Goal and Strategy to set the Quality Goal, as well as monitor result and employee performance
Provide guidance to operation personnel regarding commissioning, qualification and validation. Perform other tasks as assigned by QA department management.
Other responsibilities as required by QA management.

Minimum bachelor’s degree in biology, biotechnology, or relevant discipline

· Minimum 6 years of QA experience in the biotech/pharmaceutical industry, preferable in vaccine or biologics or commercial product experience, CDMO experience also preferred but not required.

· o Delta

V and PI software
Good understanding of cGMP requirements, GCPs, GLPs, GAMP and Part 11 compliance as applied to quality assurance, qualification of systems and validation of biotech/pharmaceutical manufacturing processes

· At least 7 years experience using KNEAT software

· Thorough working knowledge of regulations and industry best practice affecting product quality.
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