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.
Requirements
Responsibilities:
- Liaise with the Automation and Validation departments in
an effective and timely manner as part of generating Automated System Periodic
Evaluation Program (PER Program) reports.
- Responsible for generating maintenance reports as part of
the Maintenance program example review and trending of work records. Liaise
with multiple departments in data review. Collate responses in an timely and
effective manner.
- Facilitate reviews and revisions of Department related
SOP's, life cycle documents, plans and policies for each group within the
Department.
- Facilitate support of preventative maintenance record
review and audit trail review.
- Ensure report writing deadlines are meet and data is
concise and accurate and meets ALCOA+ principles.
- Support department in lead up to audit in preparation of
support documentation.
- Support automation in administration of equipment access.
- Maintains knowledge of current good manufacturing
practices (cGMPs).
Skills Required:
- Experience working in a regulated GxP environment.
- Ability to work on own initiative, without direct
supervision from management.
- Team player with an ability to work well across various
departments on site as well as business partners.
- Project management skills.
- Excellent written and communication skills.
- Deadline focused individual.
