Senior QA Consultant – Market Complaints (Solid Oral Dosage)

We are looking for experienced Quality Assurance Consultants to support a 4 -month pharmaceutical consulting project focused on Market Complaint Management for Solid Oral Dosage (OSD) products.

Experience

- 10+ years of Pharmaceutical Quality Assurance experience
- Solid experience in Solid Oral Dosage (Tablets/Capsules) manufacturing

Mandatory Skills

- Hands-on experience in Market Complaint Investigation
- Root Cause Analysis (RCA)
- CAPA development and effectiveness verification
- Review of batch manufacturing records (BMR/BPR)
- Investigation of OOS/OOT, deviations, and change controls related to complaints
- Strong understanding of Solid Oral Dosage dossiers and regulatory documentation
- Trend analysis and complaint data evaluation
- Cross-functional coordination with Manufacturing, QC, Regulatory Affairs, and Supply Chain
- Experience supporting USFDA, EMA, MHRA , or other global regulatory requirements

Preferred Experience

- Complaint handling for US, EU, or other regulated markets
- SOP preparation and review
- Product Quality Reviews (PQR/APQR) exposure (preferred, not mandatory)
- Experience with TrackWise, SAP, Veeva, EDMS, or similar QMS tools

📌 Senior QA Consultant – Market Complaints (Solid Oral Dosage) (India)
🏢 vueverse.
📍 India