Vadodara

Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.

Validation professional with expertise in qualification / validation / re-qualification of instruments, equipment & utilities; hands-on validation through electronic systems; calibration & preventive maintenance.

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.

Ph.D. in Biochemistry, Pharmacology, Chemical Biology, Cell Biology, or related discipline with years of industry experience in drug discovery.

Alembic Pharmaceuticals Ltd-Drug Discovery is seeking an Analytical Scientist with strong expertise in analytical and/or bioanalytical chemistry to support drug discovery and preclinical development programs. B.Sc./M.Sc/B.Pharm/ M.Pharm. in Chemistry, Organic Chemistry

Bachelos or Masters degree in Life Sciences, Chemistry, Biotechnology, Pharmacy, or a related field.

Operate & manage granulation, compression, coating, pelletization and capsule filling area. Operate and monitor pharmaceutical manufacturing equipment as per SOPs, BMRs, and GMP guidelines.

Experience in execution of lab scale manufacturing, reverse engineering, analytical know-how, plant level manufacturing activities; scale-up and exhibit batches based on quality principles QbD, QTPP, CQA, CMA, CPP, RA, FMEA.

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