About PSC Biotech Who are we?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. Overview:Scientific Specialist supporting the downstream
operations team. Successful candidate will be part of a Technical Operations
team supporting Operations RequirementsRole Functions:Individual will hold the position of risk lead of the
contamination control and downstream QRA (quality risk assessments- involves
owning all pre work, holding and leading reviews sessions with
interdisciplinary teams, and owning the update and approval of the QRA on the
electronic GMP system)Responsible for Downstream Quality Risk Assessments
(QRA's), including contamination control QRA's Responsibility for the timely,
accurate and efficient management of documents including access and revision
control.Hold the position of QRA contributor to other risks
assessments on site.Manage “Live” Documentation updates from the operations
floor.Turnaround and issue documentation as per Operations
ScheduleManage and implement on the floor documentation control
system.Drive the Documentation Life Cycle System to ensure
documents are approved in as per Scheduling requirements.Work with various Subject Matter Experts to ensure
technical documentation updates are approved.Creation and revision of Standard operating Procedures
(SOPs) Work Instructions (WI’s) as requiredWork closely with QA, Supply chain and Operations core
functionsEnsure compliance with all regulatory GMP, Safety and
Environmental requirements. Key Competencies & Experience:Self-motivated with excellent organizational skillsExperience Working in a Pharmaceutical GMP regulated
industry.Excellent verbal and written communication skillsAbility to work independently and as part of a team in a
cross functional collaborative environment.High level of attention to detailExperience working with GMP Documentation Management
SystemsProficient in Microsoft Office Tools
(word/excel/PowerPoint)Good interpersonal skills Qualifications:At minimum, Degree in a relevant Qualification and
Biopharmaceutical experience#LI-DM2