Vadodara

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

Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval

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.

To procure raw materials, packaging materials and Reference product in consultation with packaging / purchase department.

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.