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.Employee Value Proposition Employees are the "heartbeat" of PSC Biotech. We provide unparalleled empowering career development through 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 regarding quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.Role DescriptionAn amazing opportunity has arisen for a Vaccines IPT. The Candidate will provide validation (primarily cleaning cycle development and cleaning validation) and technical support to the Vaccines IPT team. The role will be reporting to the Vaccines IPT Associate Director.Role Functions(Functions include, but are not limited to, the following)Execute cleaning cycle development and PQ of equipment.Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.Execute run the business activities e.g., equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.Provide support during commissioning phase by reviewing and approving documents.Ensure documentation complies with standards.Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.Technical report writing, statistical analysis of data.Adherence to the latest regulatory guidelines.Represent the IPT on cross-functional project teams.Provide technical input and support and present as an SME on relevant topics during regulatory inspections.Ensure compliance with site EHS policy, c GMP and other business regulations.Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.Experience, Knowledge & Skills3-5 years' experience as a validation specialist in a pharmaceutical or a highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field. Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering. A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS and eVAL, electronic batch records.Qualifications & EducationDegree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry, or a related field.
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