QA Complaints & Documentation

[Freelancer/Consultant] Quality Assurance Specialist (QA Complaints & Documentation)Experience: 2–3 yearsDepartment: Quality AssuranceReports to: QA ManagerPosition SummaryThe Quality Assurance Specialist will support key QA activities including the management of customer complaints, Annual Product Quality Reviews (PQR/APR), packaging documentation review, and administrative tasks within the Quality Management System (QMS). The role ensures compliance with internal procedures, GMP/GDP requirements, and regulatory standards.Key Responsibilities1. QA Complaints HandlingReceive, log, and investigate product quality complaints in the QMS.Coordinate complaint investigations with internal teams (QC, Supply Chain, Manufacturing).Prepare complaint reports, CAPA recommendations, and follow-up actions.Ensure timely closure of complaint files according to KPIs and regulatory timelines.2. PQR / APR (Product Quality Review)Support the collection, consolidation, and verification of PQR/APR data.Assist in drafting and reviewing annual product quality reports.Coordinate with QC, Manufacturing, Supply Chain, and Regulatory to gather required information.Ensure PQRs are completed and approved within required timelines.3. Packaging Documentation ReviewReview and approve packaging artworks, specifications, and changes.Verify compliance with GMP, regulatory requirements, and internal standards.Maintain controlled versions of packaging documents in the QMS.4. QA Administrative SupportManage and update QA databases, logs, and documentation.Support change controls, deviations, and CAPA documentation.Maintain training records, SOPs, and controlled documents.Assist with audits (internal, external, regulatory) by preparing documentation and supporting audit execution.Qualifications & RequirementsEducationBachelor’s degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or related field.Experience2–3 years in Quality Assurance within the pharmaceutical, biotech, MedTech, or FMCG regulated industry.Experience in complaints handling, documentation management, or packaging review is highly valued.SkillsSolid understanding of GMP/GDP requirements.Strong attention to detail and organizational skills.Ability to analyze data and write clear, structured QA reports.Proficient with QMS software (TrackWise, Veeva, MasterControl, or similar).Good communication skills; able to collaborate cross-functionally.Intermediate to advanced MS Office (Excel, Word, PowerPoint).Language RequirementsFluent English.Native Italian