Overall responsible for cGMP compliance of the production functions at shop floor of OSD, Injection and Oral Liquid area.
Ensure the online documentation on the shop floor i.e. BMR and BPR.
Ensure the online documentation on the shop floor i.e. usage logbook of process equipment.
Ensure the online documentation on the shop floor i.e. cleaning logbook of process equipment.
Ensure the online documentation on the shop floor i.e. cleaning logbook of area.
Ensure the online documentation on the shop floor i.e. environmental monitoring record.
Ensure the proper labelling on the process equipment's & instruments for preventive maintenance, calibration, qualification, cleaning & status labelling.
Responsible for the review and assessment of cGMP document such as SOPs.
Ensure and compliance of SOPs for operation, cleaning, preventive maintenance and calibration of process equipment / instruments and equipment usage logbook with respect to actual practices.
Review of audit trail of process equipment / instruments.
Review the equipment operation as per the Equipment qualification protocols / reports,
Review the manufacturing activity of the products as per the Process validation protocols / reports.
Review and assessment of QMS documents i.e. deviations, OOS/ OOT, incident, change control, non-conformance, CAPA, market complaint, product recall, etc.
Responsible for review of Risk Assessment related to production department.
Responsible for performing the self-inspection in the production departments.
Review cleaning of the area & equipment as per the cleaning validation documents.
Responsible for the review and assessment of shop floor activity.
Responsible for the verify the training documents of production persons.
Responsible for the verify the F&D related documents.
Responsible to provide trainings on data integrity & current established guidelines by different regulatory authorities.
Responsible for complying with the provisions of the current pharmaceutical regulations and fully implementing the cGMP requirements at the plant.
Candidate Profile Required :-
Candidate must have the regulatory exposure of the EU/ MHRA/ USFDA audits