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.
The Quality
Specialist role:
• Participate as
functional expert in the cross functional team that manages production right first
time at site.
• Review and approve
batch, cleaning and testing documentation.
• Ensure that all
Laboratory Out of Specification (OOS) and process deviations are documented, assessed
and associated CAPA identified.
• Provide support to
deviation investigations and process performance monitoring.
Perform trending on
deviations raised as required to identify improvement initiatives.
• Provide detailed
knowledge of quality systems in place and ensure that root cause is identified and
corrective actions as appropriate are completed.
• Provide guidance on
quality requirements to maintain validation status, including participation in
process/product Risk Assessments.
• Provide feedback on
re -occurring issues ensuring continuous improvement to systems/processes.
• Ensure changes
controls raised are documented, assessed and completed.
• Prepare Annual
Process and System Reviews.
• Act as lead/team
auditor to support the internal GMP walkdown and scheduled audits.
• Participate in the
generation and communication of quality metrics.
• Creation, review and
approval of quality procedures as required.
Requirements
What skills you
will need:
In order to excel in
this role, you will more than likely have:
• Degree or
post -graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality
IT systems desirable (e.g. SAP, Trackwise).
• Knowledge and
demonstrated expertise in Lean / Continuous Improvement.
• Experience and
knowledge of GMP Requirements for Electronic /paper free
operations.
• Experience in High
potency manufacturing desirable.
• Communications:
Excellent written and oral communication skills. Organizes and delivers information
appropriately.
• Team Work: Interacts
with people effectively. Able and willing to share and receive information.
• Decision Making:
Uses sound judgement to make good decisions based on information gathered
and analysed.
• Adaptability: Adapts
to changing work environments, work priorities, organizational needs and diverse
people.
• Work Standard: Sets
and maintains high performance standards. Pays close attention to detail,
accuracy and completeness.
• Motivation: Displays
energy and enthusiasm. Maintains high level of productivity and self direction.