Vadodara

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.

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

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

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

Monitor and supervise production process to ensure compliance with SOP and cGMP. Maintain documentation as per regulatory authorities requirement like change control, deviations.