QA Validation Documentation Specialist

​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 the next 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

·        Review,
reconcile, organise, and digitise archived validation documentation.

·        Support
implementation of a new document archival system for retrospective and
prospective records.

·        Facilitate
conversion of paper records to compliant Electronic True Copy records.

·        Assess
validation document completeness, criticality, and retention requirements.

·        Support
archive reorganisation activities in partnership with CQV, Validation, and
Document Control.

·        Ensure
compliance with GMP, GDP, data integrity, and site document management
procedures.

·        Support
compliance reporting and quality system objectives related to documentation
management.

Requirements

·        BSc in
Science, Engineering, Quality, or related discipline (or equivalent relevant
experience).

·        Experience
within a pharmaceutical or other regulated quality environment.

·        Knowledge
of GMP, GDP, and data integrity requirements.

·        Understanding
of validation lifecycle documentation and CQV processes.

·        Strong
document management, organisational, and communication skills.

·        Experience
with document archival, digitisation, or electronic document management systems
is desirable.

·        Able to multi-task in fast-paced, dynamic working
environment.

Benefits