About PSC BiotechWho 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 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.A fantastic opportunity has arisen for an Operations
Excellence Technical Specialist. The Technical Specialist will work on the
Operations Excellence team, reviews constraints in the current manufacturing
process and delivering projects that directly combat these constraints.RequirementsBring energy, knowledge, innovation to carry out the
following:Support the process by wholistically reviewing the how and
why individual process steps are performed, identifying areas where
efficiencies can be made, and leading projects to deliver these efficienciesManaging EHS and Quality investigations and overseeing batch
record reviews.Provide technical support to Operation functions and
changes.Lead cross-functional problem-solving teams for
troubleshooting and investigations within Vaccines IPT.Be responsible for the completion of continuous improvement
projects to support manufacturing operations through the development of
validation schedules, master plans and validation protocols.Apply Lean Six Sigma and Lean methodologies.Represent the department on cross-functional project teams.Adherence to highest standards for Compliance (Quality and
Safety).Ensure compliance with site EHS policy, cGMP and other
business regulations and lead/co-ordinate Technical IPT input to risk
assessments, audits, regulatory inspections and incident investigations.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. What skills you will need:In order to excel in this role, you will more than likely
have:5+ years experience
in a pharmaceutical or a highly regulated environment.B.Sc. Degree or other qualification in Biochemistry,
Microbiology, Chemistry, Engineering or a related field.Project management experiences in wide-scaled and/or complex
project.Strong analytical and problem-solving skills#LI-AP1