About PSC Biotech Ltd
Who 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
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:
An amazing opportunity has arisen for a QC Bioanalytical
Analyst.
Role Functions:
· Perform and carry out a variety of routine
analytical techniques including but not limited to DNA PCR and Bioassay ELISA
testing in compliance with GMP requirements.
· Follow up-to-date practices with reference to
pharmacopoeias, specifications, regulations and industry standards.
· Support the laboratory testing schedule to
achieve an efficient QC system.
· Receive and manage samples that come into the
lab for stability, in-process, and release testing.
· Reagent preparation, cleaning, and routine
equipment maintenance.
· Maintain good housekeeping and hygiene within
the laboratory.
· Calibrate and maintain all designated laboratory
instruments.
· Participate in risk assessments, inspections,
audits, incident investigations, etc. and implement and follow-up on corrective
/ preventative measures.
· Ensure training is current for all job functions
performed.
· Order, stock and receive laboratory supplies.
· Maintain data integrity and ensure compliance
with company SOPs, specifications and cGMP regulations.
· Ensure that cGMP standards are always maintained.
· Promote and participate the implementation and
maintenance of the relevant safety programs.
Experience, Knowledge & Skills:
· 1 - 5 years laboratory testing experience in the
pharmaceutical industry.
· Relevant experience and skill set in their area
of expertise that adds value to the business; ideally in a manufacturing,
preferably in a GMP setting.
· Experience and critical skills in the area of
expertise that add value to the business, ideally bioassay and DNA tests.
· Knowledge of regulatory/ code requirements to
Irish, European and International Codes, Standards and Practices.
· Knowledge of cGMP & Laboratory Quality
Systems.
· Effective communication, presentation, and
interpersonal skills, to interface effectively with all levels of colleagues
and with external customers in a team orientated manner.
Qualifications & Education:
· Qualification in Science/Chemical
Engineering/Biological Engineering