Handling of change controls / deviations /OOS OOT /Failure / Investigation and CAPA
Handling of Reprocessing / Reworking/ Market Complaints/ Product recalls/ Return Goods/ Retention Samples/ Self Audits
Handling of Batch production records and Batch Cleaning Records
Handling of Qualification / Validation activities and its document compliance.
Review of Annual product Quality Reviews
Review and approval of master documents (e.g. SOP, Specifications, VMP, SMF etc.)
Release of finished products (API & FML) & Saleable intermediates
Coordination with other departments
Training of Personnel
Ensure GMP compliance in plants
Ensure compliance to SOP on Storage, Retrieval and Destruction of Records/ Distribution and control of documents (Specification, MTP, SOP, TDS, CDS, BPR, Drawings etc.)
Ensure compliance to various regulatory and customer inspection
Carrying out vendor audits of API, KSM, printed and primary packing materials
Coordinate with RA for fulfilling the requirements of various regulatory submission.
To ensure compliance of all regulatory documents.
Knowledge of PPE
Safety procedure to be followed during calibration at site.
Awareness about hazardous areas and precaution to be taken during operation.