QA Specialist – QC Analytical Projects

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

A QA Specialist is required for a biopharmaceutical company in West Dublin. The successful candidate will provide Quality Assurance oversight and support for QC Analytical projects, ensuring analytical methods, laboratory equipment, cleaning validation activities, and associated quality systems are implemented and maintained in compliance with cGMP, corporate standards, and regulatory requirements.

Responsibilities:

• Provide Quality Assurance oversight for QC Analytical projects, including analytical method transfers, method validation, method verification, and lifecycle management activities.
• Provide QA oversight for qualification and requalification of QC laboratory equipment, instruments, computerized systems, and supporting laboratory utilities.
• Review and approve qualification, validation, and verification documentation for analytical methods, laboratory equipment, software, utilities, and cleaning validation activities to ensure compliance with current regulatory requirements, EU GMP, FDA expectations, corporate standards, and internal procedures.
• Provide QA support for cleaning validation strategies, protocols, reports, and ongoing cleaning verification activities from a laboratory and manufacturing perspective.
• Review and approve project documentation across cross-functional teams including Quality Control, Quality Assurance, Manufacturing, Technical Services, Validation, Engineering, Facilities, Automation, and Supply Chain.
• Provide QA oversight for laboratory investigations, deviations, Out of Specification (OOS), Out of Trend (OOT), and atypical results associated with analytical testing, equipment qualification, and validation activities.
• Participate in change control activities supporting analytical methods, laboratory equipment, computerized systems, and QC processes.
• Review and approve risk assessments, validation plans, protocols, reports, and supporting documentation associated with analytical and laboratory projects.
• Provide Quality guidance on validation strategies for analytical methods, laboratory equipment qualifications (IQ/OQ/PQ), computerized systems, and cleaning validation.
• Ensure timely review and approval of GMP documentation to support laboratory project timelines and commercial testing activities.
• Support supplier qualification activities relating to laboratory equipment, analytical standards, reagents, reference materials, and contract testing laboratories where required.
• Perform QA review of laboratory procedures, specifications, test methods, sampling plans, and GMP documentation.
• Support deviation investigations, root cause analysis, effectiveness checks, and Corrective and Preventive Actions (CAPAs) arising from QC laboratory activities.
• Ensure analytical equipment qualifications, calibration, maintenance, and validation activities are completed in accordance with approved procedures and regulatory expectations.
• Provide QA support for regulatory inspections, customer audits, and internal audits relating to QC laboratories and validation activities.
• Promote inspection readiness and continuous improvement across Quality Control and Quality Assurance functions.

Qualifications & Experience:

• Third level qualification (B.Sc. or higher) in Science, Chemistry, Microbiology, Pharmacy, or a related discipline.
• Minimum of 6–8 years' Quality Assurance experience within the pharmaceutical or biopharmaceutical industry.
• Strong working knowledge of cGMP requirements, EU GMP Annexes, FDA regulations, ICH guidelines, and data integrity principles applicable to Quality Control laboratories.
• Demonstrated experience providing QA oversight for analytical method transfers, method validation, method verification, laboratory equipment qualification (IQ/OQ/PQ), and cleaning validation.
• Experience reviewing and approving validation protocols, reports, risk assessments, deviations, change controls, CAPAs, and qualification documentation.
• Strong understanding of QC laboratory operations, analytical instrumentation, computerized laboratory systems, and laboratory compliance requirements.
• Experience supporting regulatory inspections involving FDA, HPRA, EMA, MHRA, or other international regulatory agencies.
• Knowledge of laboratory computerized systems such as LIMS, Empower, Veeva Vault, TrackWise, DeltaV, or equivalent systems is desirable.
• Excellent technical writing, documentation review, and problem-solving skills.
• Strong planning, organisational, and stakeholder management skills, with the ability to manage multiple concurrent QA project activities.
• Previous experience supporting laboratory operations, validation, engineering, technical services, supplier qualification, and quality systems within a GMP-regulated environment is highly desirable.