About PSC Biotech Who we are? 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. '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. Employee Value Proposition 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. KEY ACCOUNTIBILITIES: Ÿ 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. Ÿ Accountable for review and approval of commissioning and qualification activities, including the pre and post-execution review & approval of all validation lifecycle documents. Ÿ Accountable for providing guidance on creation of equipment lifecycle documentation, e.g. 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. Ÿ Participate or lead investigation, where possible related to discrepancies identified during qualification activities Ÿ Review & approve SOPs, Deviations/Event, CAPAs, Change Controls, Periodic Maintenance plans and user access request's etc.. Ÿ Effective interfaces with internal and external stakeholders to ensure effective communication Ÿ Align with company's Quality Goal and Strategy to set the Quality Goal, as well as monitor result and employee performance Ÿ Provide guidance to operation personnel regarding commissioning, qualification and validation. Work with the team on continuous improvement activities. Ÿ Comply with company requirements on EHS Ÿ Perform other tasks as assigned by QA department management. Ÿ Other responsibilities as required by QA management. REQUIREMENTS: · 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. · Mandatory experience in one of the following – o Filling line qualification o DeltaV and PI software o HVAC and Utilities · 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 · Excellent knowledge of validation principles At least 7 years of experience using KNEAT software · Thorough working knowledge of regulations and industry best practice affecting product quality. · Familiar with questions and challenges in audits and regulatory inspections. · Experience of working effectively in a fast-paced environment · Demonstrated problem solving and facilitation skills in day-to-day practices. · Excellent written and oral communication skills, able to effectively interact cross-functionally and across all levels of the organization.
