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PSC Biotech Ltd

QA Validation Documentation Specialist

PSC Biotech Ltd Dundalk, Leinster, Ireland

Biotechnology Research · 201-500 employees

4 d ago
qa Mid (2-5 yrs) Contractor Ireland
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About the role

The specialist will review, reconcile, and digitize archived validation documentation while supporting the implementation of new archival systems. They will ensure compliance with GMP, GDP, and data integrity standards across all site document management procedures.

What they look for

Validation documentation GMP GDP Data integrity Document management Archival systems Digitisation Quality assurance CQV processes Compliance reporting Regulatory inspections Pharmaceutical industry Biotechnology Validation lifecycle Document control

Requirements

Candidates must hold a BSc in Science, Engineering, or Quality and possess experience within a regulated pharmaceutical environment. A strong understanding of validation lifecycle documentation, GMP, and GDP requirements is essential for this role.

Full description

​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

Role Functions

· 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

9 Month Contract

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