QA Validation Documentation Specialist

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

Role Functions

• Review,reconcile, organise, and digitise archived validation documentation.
• Supportimplementation of a new document archival system for retrospective andprospective records.
• Facilitateconversion of paper records to compliant Electronic True Copy records.
• Assessvalidation document completeness, criticality, and retention requirements.
• Supportarchive reorganisation activities in partnership with CQV, Validation, andDocument Control.
• Ensurecompliance with GMP, GDP, data integrity, and site document managementprocedures.
• Supportcompliance reporting and quality system objectives related to documentationmanagement.

Requirements

• BSc inScience, Engineering, Quality, or related discipline (or equivalent relevantexperience).
• Experiencewithin a pharmaceutical or other regulated quality environment.
• Knowledgeof GMP, GDP, and data integrity requirements.
• Understandingof validation lifecycle documentation and CQV processes.
• Strongdocument management, organisational, and communication skills.
• Experiencewith document archival, digitisation, or electronic document management systemsis desirable.
• Able to multi-task in fast-paced, dynamic workingenvironment.