Gujarat

2 TO 8 YEARS YEARS OF EXPERIENCE IN COMPRESSION, GRANULATION AND PACKING. EXPERIENCE IN RECEIPT & DISPENSING ACTIVITY, INWARD & OUTWARD ACTIVITY

eCTD Compilation, validation, and submission to Health Canada and US through ESG gateway for New Submission ANDS, NDS, Deficiencies response Clarifax, SDN, NOD, NON, Supplements submissions

Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing or fresher also apply. Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing.

To implement, manage and ensure the functions of GCP, GLP Quality Assurance program that will assure all BA, BE studies and clinical studies to withstand regulatory scrutiny.

HPLC Analyst, Operation of HPLC, Troubleshooting, Analysis of all In-process, Intermediates, RM, PM, Finish Product, Stability samples and other analytical samples of lab. Operation of GC, IR, UV, KF, Auto titrator, SOR and Wet Lab analysis.

Management and performing periodic observation of retain sample & identified the deviation through periodic observation. Review of Temperature, RH data in retained samples area.

Filling machine Groninger, Optima, Dyno Truking filling and sealing machine, Bosch filling machine, Steam sterilizer Fedegree

Ph.D. in Science, Engineering, Technology, Veterinary Science, Pharmacy. Candidate must possess certificate, marksheet of basic knowledge of Computer from training institute or should have results with computer as a subject in degree or diploma curriculum from Government approved University or should have passed 10th or 12th examination with computer as a subject as prescribed by GAD in Government Resolution

The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.  Should keep the all the regulatory database up to date. Candidate must possess do it right the first-time approach with proven track record. 

Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating, Capsule filling, Primary Packing and Secondary Packing. Expertise in e-BPR and e-log will be added advantage.