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 Proposition
Employees 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:
A fantastic opportunity has arisen for a Validation
Specialist. The successful candidate will take a lead on utilising the latest
innovations in technology. The role is based at the Drug Substance and Drug
Product Facility which is a new facility build working to obtain qualification
and continued product development. The site is the first facility in the network focused on manufacturing a live virus
vaccine.
Requirements
Responsibilities:
* Support the site validation activities across a number of
workstreams.
* Develop and maintain the site Validation Master Plan.
* Drive development of site EMPQ strategy and
implement/maintain EM protocols and procedures for graded pharmaceutical areas,
ensuring compliance with regulatory guidelines.
* Perform/involved in risk based EM assessments to
determine the environmental monitoring requirements.
* Oversee EMPQ validation studies, ensuring proper
execution, data collection, and documentation.
* Collaborate with production and quality control teams to
establish EM procedures, sampling routines and requirements.
* Draft, review and approve validation documentation,
reports, and deviation investigations.
* Periodic classification of areas/EM programs to ensure
their ongoing effectiveness.
* Support equipment qualification post Operational
Qualification (OQ) through to Process Performance Qualification (PPQ) and
subsequent revalidation.
* Support global regulatory submissions, internal audits
and external inspections/audits as needed.
* Facilitate problem solving & risk assessment
projects/meetings.
* Making problems visible and strive for continuous
improvement.
* Lead and support various organizational initiatives as
needed (examples include safety, financial forecasting, work standardization,
etc).
* Keep up to date with scientific and technical
developments.
* Maintain continuous focus on quality and safety
compliance and unflinching focus on the customer.
Skills Required:
o 3 -5 years direct experience with a pharmaceutical or
biotechnology company with a working knowledge of current regulatory
requirements and current Good Manufacturing Practices.
o Bachelor's degree (or higher) in Biological
Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
o Prior experience in Cleaning Validation, Temperature
Mapping activities, and qualification of Parts Washers and/or Autoclaves.
o Experience with upstream cell culture and/or downstream
formulation/fill finish processes.
o Experience with technology transfer, regulatory filing,
and commercial drug substance/drug product manufacturing of biologics.
o Prior experience in drug substance/drug product, process
performance qualification and validation, site readiness and authoring
regulatory CTD sections.