QA Validation Documentation Specialist

PSC Biotech; Dundalk; On-site; EUR 32,000 - 52,000; Full time

Job summary

PSC Biotech is seeking a detail-oriented documentation specialist to review, reconcile, organise, and digitise archived validation records within its Ireland quality team. You will help implement a new archival system, convert paper records to electronic True Copy formats, and ensure records meet GMP, GDP, and data integrity standards.

The role requires a BSc in Science, Engineering, Quality, or related discipline, plus experience in a regulated pharma environment and strong communication and

Qualifications

• BSc in Science, Engineering, Quality, or related discipline.
• Experience in a regulated pharma environment.
• Knowledge of GMP, GDP and data integrity requirements.

Responsibilities

• 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.

Skills

Document management

Organisational skills

Communication

Education

BSc in Science/Engineering/Quality

Job description

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.