QA Complaints

[Freelancer/Consultant] Quality Assurance Specialist (QA Complaints & Documentation)

Experience: 2–3 years

Department: Quality Assurance

Reports to: QA Manager

Position Summary

The 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 Responsibilities

1. QA Complaints Handling

- Receive, 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 Review

- Review 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 Support

- Manage 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 & Requirements

Education

- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or related field.

Experience

- 2–3 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.

Skills

- Solid 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 Requirements

- Fluent English.
- Native Italian