Remote CSV & Compliance Specialist – Pharma

Y-Axis; Dublin; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Indeed Ireland is seeking a Clinical Compliance Operations Specialist to support pharmaceutical manufacturing validation and compliance activities in Dublin. The role focuses on authoring and managing C&Q Plans, risk assessments, URS documents, and data integrity assessments, with input from SMEs.

The candidate will monitor FAT/SAT and IOQ execution, ensuring alignment with test scripts and regulatory requirements such as 21 CFR Part 11, EudraLex Annex 11 and GAMP 5.

Qualifications

• Experience with validation, QA and CSV in pharmaceutical manufacturing environments.
• Familiarity with regulatory frameworks (21 CFR Part 11, EudraLex Annex 11, GAMP 5).
• Ability to author and manage CQ plans, risk assessments and URS documentation.

Responsibilities

• Author and manage C&Q Plans and Risk Assessments with input from SMEs.
• Monitor FAT/SAT and IOQ execution, identifying issues and providing solutions.
• Ensure FAT/SAT and IOQ execution aligns with test scripts and intent.
• Execute tests on lines, systems and equipment that are CSV related.
• Ensure automation deliverables comply with applicable regulations and industry best-practice guidance.

Skills

Pharmaceutical Manufacturing

Job description

Indeed Ireland is seeking a Clinical Compliance Operations Specialist to support pharmaceutical manufacturing validation and compliance activities in Dublin. The role focuses on authoring and managing C&Q Plans, risk assessments, URS documents, and data integrity assessments, with input from SMEs.

The candidate will monitor FAT/SAT and IOQ execution, ensuring alignment with test scripts and regulatory requirements such as 21 CFR Part 11, EudraLex Annex 11 and GAMP 5.