QA Specialist – Analytical Validation

Role Overview

The QA Specialist will provide independent quality oversight for analytical method validation and Quality Control laboratory activities within a GMP-regulated pharmaceutical or biopharmaceutical environment.

Based within the Quality Assurance team, the role will focus primarily on reviewing and approving analytical documentation, laboratory data, investigations and validation deliverables. The successful candidate will ensure that laboratory activities and records meet scientific, procedural, data-integrity and regulatory expectations.

Key Responsibilities

• Review and approve analytical method-validation protocols, executed records, data packages and final reports.
• Assess validation strategies, acceptance criteria and applicable parameters, including accuracy, precision, specificity, linearity, range, robustness, detection limit and quantitation limit.
• Review analytical data, calculations, chromatograms, instrument outputs, statistical evaluations and supporting records for accuracy, completeness, traceability and GMP compliance.
• Review documentation associated with method qualification, verification, transfer, optimisation and lifecycle changes.
• Provide QA oversight for routine and non-routine QC activities involving raw materials, in-process samples, drug substance, drug product and stability samples.
• Review laboratory deviations, atypical results, Out-of-Specification and Out-of-Trend investigations.
• Assess investigation scope, root cause, product or compliance impact, CAPAs and effectiveness checks.
• Review and approve laboratory change controls, quality risk assessments, SOPs, analytical methods, specifications and technical assessments.
• Provide QA oversight for laboratory equipment qualification, calibration, maintenance and continued compliant use.
• Ensure laboratory records and electronic data comply with Good Documentation Practices and data-integrity requirements.
• Work closely with QC, Analytical Development, Process Development, Manufacturing, Validation and other Quality stakeholders to resolve compliance issues.
• Support inspection readiness, internal audits and regulatory inspections involving analytical methods, laboratory data and validation activities.

Process Characterisation Oversight

• Review analytical plans, protocols, data packages, technical assessments and reports supporting Process Characterisation Studies, where applicable.
• Assess whether analytical data are complete, scientifically justified and suitable for evaluating the relationship between process parameters and product quality attributes.
• Provide quality guidance on study deviations, data interpretation, documentation gaps and report closure.

Candidate Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Science, Biotechnology, Life Sciences or a related discipline.
• Relevant experience in QA, QC, Analytical Science or laboratory compliance within a pharmaceutical, biotechnology or another GMP-regulated environment.
• Strong understanding of the analytical method-validation lifecycle.
• Experience reviewing method-validation protocols, executed laboratory records, raw data and final reports.
• Practical knowledge of analytical laboratory operations and techniques such as HPLC, UPLC, GC, UV-Vis or comparable methods.
• Working knowledge of GMP, Good Documentation Practices and data-integrity requirements.
• Familiarity with laboratory deviations, OOS/OOT investigations, CAPA, change control and quality risk management.
• Strong scientific judgement, attention to detail, technical-writing and data-review skills.
• Able to provide independent quality oversight while collaborating effectively with laboratory and cross-functional stakeholders.

Preferred Experience

• Experience supporting or reviewing Process Characterisation Studies.
• Exposure to analytical method transfer, method verification, NPI or laboratory equipment qualification.
• Familiarity with chromatography data systems, LIMS or other regulated electronic laboratory systems.