Indore, Madhya Pradesh
Ø Co-ordinate with internal department i.e Quality Assurance, Process Development Lab and Regulatory Affairs with respect to documentation activity
Ø Pro actively initiate change control taking approval from impacted department, affected document revised according to proposed change and closure after implementation.
Ø Preparation of Batch Production Record w.r.t Drug Development Report recommended by R&D / Process Write up, made correction as per reviewed draft copy by concern department taking approval from various department through e-BPR system.
Ø Preparation of new SOPs, find the gap between existing SOP vs. practice and modified by taking change control.
Ø Preparation of Process performance Qualification protocol and compilation of report.
Ø Initiate deviation, Corrective action and preventive action if any observed.
Ø Responsible for preparation of Risk Assessment document.
Ø Responsible for training and development of all production personnel’s through SABA learning system to meet product quality as per regulatory requirement by following GMP norms.
Ø Responsible for self audit as predetermined frequency.
Ø Responsible for audit preparation as per GMP requirement
Ø Routine checking of all logs related to operations of the plant.
Ø Taking Plant round and discuss with production manager and discuss action against discrepancies noticed.
Ø Review of quality documents (i.e Batch Production Record, change control, deviation Corrective action and preventive action, validation report, Qualification documents) prior to Audit,
Ø Issuance and retrieval of records, log sheet,
Ø Look after house keeping & safety of plant.
Lupin limited,pithampur , SEZ, Phase-II, Indore, Madhya Pradesh, IN - 452001