QA Lead — QC Analytics & Validation Programs

Tandem Project Management Ltd.; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

Tandem Project Management Ltd. is seeking a QA Specialist for a biopharmaceutical company in West Dublin.

You will provide QA oversight for QC Analytical projects, ensuring analytical methods, equipment, and cleaning validation activities meet cGMP and regulatory requirements. Responsibilities include reviewing documentation, supporting validation and verification activities, and collaborating across Quality Control, Manufacturing, Validation, and Engineering teams to maintain inspection

Qualifications

• Third level qualification in Science-related field (B.Sc. or higher).
• 6–8 years' QA experience in pharma/biopharma.
• Strong working knowledge of cGMP, EU GMP Annexes, FDA regulations and ICH guidelines.

Responsibilities

• Provide QA oversight for QC Analytical projects, including method transfers, validation, verification, and lifecycle management.
• Oversee qualification and requalification of QC lab equipment, instruments, and computerized systems.
• Review and approve qualification, validation, and verification documentation for analytical methods and equipment.

Skills

QA Oversight

cGMP Knowledge

Data Integrity

Regulatory Compliance

Analytical Method Validation

Education

B.Sc./Higher in Science/ Chemistry/ Microbiology/ Pharmacy

Tools

LIMS

Empower

Veeva Vault

TrackWise

DeltaV

Job description

Tandem Project Management Ltd. is seeking a QA Specialist for a biopharmaceutical company in West Dublin.

You will provide QA oversight for QC Analytical projects, ensuring analytical methods, equipment, and cleaning validation activities meet cGMP and regulatory requirements. Responsibilities include reviewing documentation, supporting validation and verification activities, and collaborating across Quality Control, Manufacturing, Validation, and Engineering teams to maintain inspection