4-5

Exposure of QMS activities Exposure of Ampho, Bupivacaine Autoclave Operation and Supervision Lyo Operation and Supervision Regulatory Audit exposure Online documentation of BMR and log books during execution of batches

In-Process, FG and Stability, Analytical Instrumentation - HPLC, UV and Dissolution

Hands on experience in compiling and review of the dossiers for ASEAN Markets, AFRICAN Region, Middle East and GCC Region, LATAM Region including Brazil and Mexico. Well versed with CTD and ACTD dossier compilation and registration requirements.

Candidate should have knowledge of packing operations. Knowledge of BQS, Autocarnator and Bottle packing. Responsible to adherence cGMP guidelines.

To be an integral part of an antibody development team with a focus on performance and specificity using innovative molecular, protein, and cell biology methods.

Pharma knowledge of Solid orals & Quality process. USFDA, MHRA, ANVISA & Other regulatory exposure is preferred including ICH guidelines.

Analytical Method development. Handling HPLC, GC, UV IR, KF, Dissolutions

FFS, LVP, Flow wrapping, SHWSS, Terminal Sterilizer, Dry powder injection, Injection Labelling, Capsule Filling, Compression, Granulation, Coating

Experience in metabolite identification studies including proposing potential metabolite structure and determination of tentative structures of metabolites and their product ions from the LC-MS/MS data