5+

Experiences in HPLC/ GC/ IR/ UV/ Dissolution/ Polarimeter/ Potentiometric titrations/ KF/ PSD by Malvern. Awareness on current Data Integrity requirements & cGMP requirements. Stability studies

Stability & validation samples analysis, OOS/OOT handling and documentation, GMP / GLP compliance & data integrity

Responsible and Accountable for Preparation / Compilation of registration, re-registration dossier and variation application as per registration guidelines for various countries.

Seeking an experienced Site Manager - Clinical Trials to lead and oversee end-to- end clinical trial execution and site administration. The ideal candidate will be responsible for ensuring regulatory compliance, operational excellence, staff management, sponsor/CRO coordination, and smooth day-to-day site functioning across multiple studies.

Handling of Change Controls, CAPA's, Unplanned Deviations, Planned Deviation, Investigations and Audit Management in Trackwise software

To have knowledge of ICH guidelines and other regional regulatory requirements including USFDA, EMA, NMPA, TGA, CADIFA and other global regulatory market.

Sun is building the future of healthcare. We invite passionate professionals to join India's No. 1 pharmaceutical company and help deliver medicines that change lives worldwide.

Build and maintain long-term, trust-based relationships with healthcare professionals. Understand customer needs and offer effective solutions.

Seasoned experience in handling of various EU procedure like DCP, MRP, National. National phase handling for EU procedures.

Raw material & finished product analysis. HPLC / GC / UV/ IR / Dissolution testing. Stability & validation samples analysis, OOS / OOT handling & documentation