- Handling and evaluation of QMS activities (incidents, change controls, deviations, Internal audits, etc.).
Ensure documentation complies with data integrity and compliance with ALCOA+ principles.
- Review of Process development (Development report, risk assessment, Spec. justification etc..) and analytical documents (development reports, spec and MOA and method validation documents).
- Review of Vendor qualification documents
- Ensure effective root cause analysis (RCA) and CAPA for investigations (OOS/OOT/Incidents/deviations).
- Handling of phase gate and Tech. transfer activities.
- Collaborate on resolving any gaps or issues identified during the technology transfer process.
- Oversee DQA requirements during scale-up and technology transfer to manufacturing.
- Foster a culture of compliance, ownership, and continuous improvement.
- Handling of customer calls related to CMS projects and ensuring address of all customers related queries within the timeline.
- Participating in the teleconferences to clarify the customer queries.
- Coordination with Cross-functional teams to meet the project timelines.
Must Haves:
- Master’s degree in chemistry/Analytical chemistry.
- Experience in CMS projects development: proficient in handling customer calls and responding to technical and quality-related queries.
- Experience in Generic Drug substance development.
- Knowledge of ICH guidelines and USP general chapters.
- Handling of Quality management system activities.