5+

Responsible for coordination with all sales personnel across India for providing them appropriate Product and Sales Support.

Analytical method validation raw data and report review for different techniques like LC-MS/GC-MS/ICP -MS/ICP OES-MS for all regulated markets, Characterization & GMP Batch analysis.

Should have experience in the operation and calibration of GCMSMS / LCMSMS. Method development and validation; Preparation of reports.

Responsible for FG testing, stability studies and analytical validation. Handling in-process QA, line clearance and compliance monitoring

Biological E. Limited invites experienced, dynamic and self-motivated candidates with 2 to 9 years of experience for the below positions at its Vaccine Business, Shamirpet, Hyderabad.

Alembic Drug Discovery is seeking an experienced and high-performing Immunologist and In Vivo Strategist to drive target identification and translational pharmacology efforts across oncology, immunology, inflammation, and other disease areas.

Experience in Regulatory Affairs - Knowledge of Blueprint reviews and approvals process, Veeva Vault systems, Office-365 applications.

Review PVAs to ensure the quality of the new / revised PVAs and verify that they are consistent with company requirements. Address company comments and Collaborating Company’s comments as applicable for PVAs

Candidate should have exposure in Process Validations, Cleaning, Hold time studies. Qualification, Requalification, Validations revalidations of manufacturing equipment & Process.

Handle Product Quality Complaints, Root Cause Analysis and CAPA. Manage Change Control, Deviations, OOS/OOT and Compliance Activities