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 LevelPSC 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 PropositionEmployees 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.Our client are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.Job ResponsibilitiesThis position is responsible for 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.Provide quality oversight for validation activities related to products and facilities, utilities, equipment (FUE).Support the development of validation plans for specific system implementation projects.Supporting and reviewing/approving (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.Support validation policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the client validation techniques/approaches and systems utilizedLead and represent QA Validation in multi-departmental meetings & project teams.Identifies and implements improvements to the QA Validation systems.Participation in the change control program for modifications to qualified systems.Quality oversight for the Revalidation Evaluation program.Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required. Apply a risk management approach to identify, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risksEducationBachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.Experience+3 years’ experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.Organizational and management skills to coordinate multi-discipline project groupsAbility 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.
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