- Manage stability studies and ensure compliance with ICH and regulatory guidelines.
- Review and approve stability protocols, reports, OOS/OOT investigations, and CAPAs.
- Oversee stability chamber qualification, monitoring, and maintenance.
- Ensure GMP, GDP, and Data Integrity compliance.
- Support regulatory submissions, inspections, and customer audits.
- Collaborate with QC, Production, R&D;, Regulatory Affairs, and Engineering teams.
- Lead and develop the QA Stability team.
Preferred candidate profile We are looking for an experienced Manager QA Stability to lead and manage the stability program for pharmaceutical products. The role involves ensuring compliance with ICH and global regulatory guidelines, overseeing stability studies, reviewing stability data, managing stability chambers, and supporting regulatory audits and product lifecycle activities.