QA Validation Specialist – Lab 6 mth contract

Cashel - Ireland

Monthly Salary: Not Disclosed

Experience Required: 5years

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

Required Skills:

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 Education:

Education and QualificationsBachelors or Masters degree in one of the following disciplines:Pharmaceutical Sciences Chemistry Biotechnology Life Sciences Engineering Information Technology / Computer ScienceMinimum 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

QA Validation Specialist Lab 6 mth contractSummary: 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 manage...

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.