JOB RESPONSIBILITIES:

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.