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Urgent! QA Validation Specialist – Lab 6 mth contract - Local Job Opening in Cashel

QA Validation Specialist – Lab 6 mth contract



Job description

QA Validation Specialist Lab 6 mth contract Summary: QA Validation role to ensure Qualification of LIMS and Laboratory instruments is performed in compliance with regulatory requirements, company policy and procedures.

Key Responsibilities: Support the introduction, implementation, and lifecycle management of LIMS, Empower and other Lab software within QC and analytical laboratories.

Serve as QA Validation SME, overseeing Computer System Validation (CSV) activities, including URS, FS, RA, IQ, OQ, PQ, and validation reports.

Ensure compliance with EU GMP, FDA, EMA, and Annex 11 standards for electronic systems.

Collaborate with Quality, QC, Manufacturing, IT, and Regulatory teams to optimize lab workflows supporting product testing.

Support integration of analytical instruments and other quality systems with LIMS.

Provide user training, troubleshooting, and continuous improvement support for lab personnel.

Drive change control, deviation management, and periodic review processes related to LIMS and associated systems.

Maintain audit readiness, ensuring documentation and processes align with corporate and regulatory requirements.

Qualifications & Experience: Bachelors or Masters degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or IT/Computer Science.

5+ years experience in the pharmaceutical/medical device industry with a focus on QC laboratory software, LIMS implementation, and validation or Empower upgrades.

Strong expertise in CSV methodology, validation protocols, and regulatory frameworks.

Comprehensive knowledge of cGMP, pharmacopeial standards (USP, EP, JP), and global regulatory guidelines (FDA, EMA).

Skilled in equipment and analytical instrument qualification, calibration, and validation maintenance.

Excellent documentation skills, including accurate preparation and maintenance of SOPs, validation protocols, and technical reports.

Proven project management abilities, ensuring adherence to timelines, budgets, and quality standards.

Deep understanding of data integrity principles, validation documentation, and regulatory compliance.

Effective problem-solver in validation challenges, providing practical and risk-based solutions.
Education and Qualifications
Bachelor’s or Master’s degree in one of the following disciplines:
Pharmaceutical Sciences ,Chemistry, Biotechnology, Life Sciences Engineering, Information Technology / Computer Science
Minimum 5 years’ experience in the pharmaceutical or medical device industry, specifically within:
QA Validation or Computer System Validation (CSV)
QC Laboratory software and systems (e.g., LIMS, Empower)
Laboratory instrument qualification and validation

5+ years
Strong knowledge of Computer System Validation (CSV) principles and lifecycle management.

Hands-on experience with LIMS and Empower implementation, validation, and maintenance.

Proficiency in qualification activities (IQ, OQ, PQ) for laboratory instruments and systems.

Deep understanding of regulatory standards – EU GMP, FDA, EMA, Annex 11, and GAMP 5.

Comprehensive grasp of cGMP and pharmacopeial standards (USP, EP, JP).

Expertise in data integrity and good documentation practices (GDP).

Ability to prepare, review, and approve validation protocols, reports, and SOPs. Experience with change control, deviation management, and periodic review processes.

Strong analytical and problem-solving abilities with a risk-based approach.

Effective communication and collaboration with cross-functional teams (QA, QC, IT, Manufacturing).

Excellent documentation and technical writing skills.

Project management skills — managing validation deliverables within timelines and quality standards.

Experience in audit readiness and supporting regulatory inspections.

Ability to train, guide, and support laboratory users on validated systems.

Educational background in Science, Engineering, or IT with 5+ years’ pharmaceutical or medical device experience.


Required Skill Profession

Other General



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