Gujarat

Project Managers provide business and technical leadership for one or more projects within a business unit, leading project teams through the identification, justification, prioritization, initiation, development and implementation processes. This Sr. Specialist position will act as a Project Manager leading commercial launches in US and Global markets within the Pharmaceutical Business segment.

Evaluation and submission of application on online portal for getting domestic manufacturing and marketing permission from DCGI. Evaluation and submission of applications on online portal for import registration, import license of drugs and medical devices in India. 

Ph.D degree in relevant field and first class or equivalent at either Bachelors or Masters level in the relevant branch. AND Minimum of 10 years of experience in teaching, research, industry out of which at least 3 years shall be at a post equivalent to that of an Associate Professor.

Candidate acquainted of Quality Management System Document like Change control, Deviation and their Investigations, CAPA and Audit Management. This role will focus on ensuring the highest standards of quality throughout the manufacturing process, specifically for active pharmaceutical ingredients

HPLC, GC, IR, UV, Dissolution and other QC Equipment, QC Method Validation and Transfer.

M.Pharm / B.Pharm / MSc; Ensure line clearance, reviewing of BMR and BPR , handling shop floor QMS document. Ensuring shop floor compliances and handling of investigation. Manage granulation, compression, coating, pelletization and capsule filling area. Handle instruments like HPLC, GC,UV-visible/IR spectrophotometer, dissolution apparatus, KF, IPC-OES.

M.Pharm / MSc; Experience in Analytical Method Development of Assay, Related Substances and Dissolution method for oral solid dosage form. relevant experience with OSD products for Regulatory Market in the Analytical Department.

M.Pharm / B.Pharm / M. tech / B. tech / B.E. / B.sc / Diploma / ITI; Tablet, Capsule - Granulation, Compression, Coating, Inspection, Capsule Filling and Wurster coater. HPLC, GC, IR, UV, Dissolution and other QC Equipment, QC Method Validation and Transfer.

HPLC, GC, IC method development, Validation and Transfer for API, complex OSD, complex generics products like long acting injectables, nasal sprays, peptide injections, peptide OSDs, oncology and Topical products etc using various analytical technique. Expertly in peptide characterization. Well versed with USP/EP/BP/IP and various current regulatory guidelines ICH/ EMEA/ FDA Hands on experience on Nitrosamine and Genotoxic impurities method development, M.Pharm / M.Sc