Clinical Compliance Operations Specialist

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

Clinical Compliance Operations Specialist at Indeed Ireland

DUBLIN, Dublin County, Ireland - Full Time

Start Date

Immediate

Expiry Date

08 Dec, 26

0.0

Posted On

09 Sep, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Pharmaceutical Manufacturing

Description

• Authoring and managing the following (with input from SMEs): C&Q Plan & Risk assessments, Automation Validation Plans, URS documentation / Data Integrity Assessment/ System Impact Assessment / RTMs, FAT/SAT documentation, IOQ documentation and Summary Reports.
• Monitor FAT/SAT and IOQ execution activities, proactively identifying protocol execution issues and providing solutions.
• Ensure FAT/SAT and IOQ execution aligns with the intent of the test scripts.
• Executing tests on lines, systems and equipment that are CSV related.
• Ensure all automation deliverables comply with applicable regulations and industry best-practice guidance such as 21 CFR Part 11, EudraLex Annex 11, and GAMP 5.