Responsible for coordination with various departments like Regulatory Affairs, Manufacturing, Warehouse, Quality Assurance, Quality Control, Engineering for execution of Scale-up and Exhibit batches and reviewing GMP related documents.
To file amendments and deficiency response within timelines with go getter approach. The job requires review of documents related to DMF submission against predefined checklists and submission to various agencies globally.
B.Pharm/ M.Pharm. BSC/MSC. Experience in analysis of RM, Finish, In Process, Stability samples by using instruments like HPLC, UV-visible spectrophotometer, dissolution apparatus, GC chromatography, IR spectrophotometer and AAS.
Daily routine analysis Wet lab and Instrument, Manage data records for the lab activities, Manage documentation of lab experiments, Co-ordinate with R&D for daily analysis.
Degree in Pharmacy or Diploma in Pharmacy or its equivalent qualification obtained from The candidate should be registered under Pharmacy Act 1948 and registered with Gujarat Pharmacy Council is required.
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.