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.We offer a permanent contract of employment giving exposure to 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 through learning & development, in‑house training, mentorship and constant guidance to facilitate career progression.OverviewA high level of initiative, energy and motivation are key role requirements, as well as organizational skills.This position is responsible for supporting the quality oversight of validation activities in a GMP regulated environment, incorporating implementation, requalification and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.ResponsibilitiesKey Subject Matter Expert (SME) and quality oversight representative in specific validation discipline(s).Maintains current knowledge of industry standards and regulatory requirements for validation techniques/approaches utilized.Supports the QA Validation group in maintaining regulatory compliance, in line with industry best-practices in specific validation discipline(s).Supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise.Supports strategy development and ensures regulatory compliance for validation projects. Strategically supports complex validation projects across a variety of disciplines.Provision of mentorship and SME support to more junior members of the QA Validation team and cross‑functional groups as applicable.Lead and represent QA Validation in multi‑departmental meetings & project teams.Identifies and leads implementation of improvements to validation systems.Quality oversight for validation execution activities related to the various validation disciplines. This includes supporting and reviewing/approving validation lifecycle documentation e.g. URS, risk assessments, commissioning documents, qualification protocols, revalidation/periodic review reports.Supports development of validation plans for specific system implementation projects.Establishes site validation policies, through development, generation and implementation of site validation master plans, guideline documents and SOPs.Provide quality oversight for any assigned change requests, deviations, quality events and associated CAPAs. Other duties as assigned.EducationBachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.Experience+5 years’ experience in a cGMP regulated manufacturing environment, with demonstrated knowledge of facility, equipment, utility, process, lab systems and CSV validation.Organizational and management skills to coordinate multi‑discipline project groups.Ability to speak, present data, and defend approaches in front of audiences and inspectors.Ability to comprehend technical information related to equipment, processes, and regulatory expectations.Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.ContactsThis position will require interaction with multiple levels (from technicians up through senior management) in engineering, quality assurance, quality control, corporate compliance, manufacturing, manufacturing sciences, facilities, regulatory affairs, accounting, and human resources.
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