About PSC Biotech Ltd Who we are? PSC Biotech is aleading Biotech Consultancy firm founded in 1996, headquartered in Pomona,California, USA, with Global operations in Ireland, India, Singapore, Australiaand the US, serving 350 clients in more than 23 countries worldwide. We providecloud -based software solutions for Quality Management and RegulatoryInspections, pharmaceuticals contract manufacturing professionals, andmetrology services to our clients. 'Take your Career to anew Level' PSC Biotech disruptsthe conventional consultancy model by aligning our EVP as one of the uniqueselling point which includes the opportunity to work with the most talentedcohort of like -minded professionals operating in the Pharma/ BiotechIndustry. We offer a permanent contract of employment givingexposure of working in Top Pharmaceutical client sites in a diverse -culturalwork setting. Employee ValuePropositionEmployees are the"heartbeat" of PSC Biotech, we provide unparalleled empowering careerdevelopment though Learning & Development in -house training mentorshipthrough constant guidance to facilitate career progression. We believe increating high performing teams that can exceed our client's expectations withregards to quality of all scalable and business unit deliverables, stayingunder budget and ensuring timelines for our deliverables are being met.
Responsibilities:
· Accountable to provide quality oversight tovalidation and equipment qualification activities to ensure these activitiesare compliant with all applicable regulations, company and contractualobligations.· Accountable for review and approval ofcommissioning and qualification activities, including the pre andpost -execution review & approval of all validation lifecycle documents.· Accountable for providing guidance on creationof equipment lifecycle documentation, e.g. URS, FAT, SAT, IQ, OQ, PQ protocolsand reports, risk assessments, technical specifications, 21 CFR Part 11assessment, Data Integrity Assessment, Configuration Specifications, Designspecifications.Participate or lead investigation, where possible related todiscrepancies identified during qualification activities· Review & approve SOPs, Deviations/Event,CAPAs, Change Controls, Periodic Maintenance plans and user access request'setc..· Effective interfaces with internal and externalstakeholders to ensure effective communication· Align with company's Quality Goal and Strategyto set the Quality Goal, as well as monitor result and employee performance· Provide guidance to operation personnelregarding commissioning, qualification and validation. Work with the team oncontinuous improvement activities.· Comply with company requirements on EHS
· Perform other tasks as assigned by QA department:· Accountable to provide quality oversight tovalidation and equipment qualification activities to ensure these activitiesare compliant with all applicable regulations, company and contractualobligations.· Accountable for review and approval ofcommissioning and qualification activities, including the pre andpost -execution review & approval of all validation lifecycle documents.· Accountable for providing guidance on creationof equipment lifecycle documentation, e.g. URS, FAT, SAT, IQ, OQ, PQ protocolsand reports, risk assessments, technical specifications, 21 CFR Part 11assessment, Data Integrity Assessment, Configuration Specifications, Designspecifications.Participate or lead investigation, where possible related todiscrepancies identified during qualification activities· Review & approve SOPs, Deviations/Event,CAPAs, Change Controls, Periodic Maintenance plans and user access request'setc..· Effective interfaces with internal and externalstakeholders to ensure effective communication· Align with company's Quality Goal and Strategyto set the Quality Goal, as well as monitor result and employee performance· Provide guidance to operation personnelregarding commissioning, qualification and validation. Work with the team oncontinuous improvement activities.· Comply with company requirements on EHS· Perform other tasks as assigned by QA department
Requirements· Minimum bachelor's degree in biology,biotechnology, or relevant discipline· Minimum 6 years of QA experience in thebiotech/pharmaceutical industry, preferable in vaccine or biologics orcommercial product experience, CDMO experience also preferred but not required.· 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 manufacturingprocesses· Excellent knowledge of validation principles· Thorough working knowledge of regulations andindustry best practice affecting product quality.· Familiar with questions and challenges in auditsand regulatory inspections.· Experience of working effectively in afast -paced environment· Demonstrated problem solving and facilitationskills in day -to -day practices.· Excellent written and oral communication skills,able to effectively interact cross -functionally and across all levels of theorganization.