To ensure implementation of cGMP norms in manufacturing areas
To give line clearance in dispensing, manufacturing and packaging
To monitor dispensing, manufacturing and packaging
Sampling of In-process, finished stage and process validation batches and forwarding the same to Quality Control department for analysis
To ensure that gowning and entry/ exit procedures are followed as per standard procedures
Monitoring of environmental conditions (temperature, humidity & pressure differential) in manufacturing areas
To carry out IPQA checks in manufacturing and packaging areas
To ensure online documentation
To verify that the appropriate qualification, calibration and preventive maintenance of instruments/equipment are done as per frequency during line clearance
To ensure the destruction of used Stereo, semi finished and finished product left over
Responsible for withdrawal of control sample and stability samples of finished product
Review of BMR, BPR etc
Responsible for AQL of Finished goods (tablets and capsules)
Maintain the continue process verification for all products
Fulfill the regulatory requirements of RA department
To verify the assigned batch number, Mfg date, Exp date to finished products for in house and loan license products
Monitoring of training activity in entire plant as per scheduler
Maintenance of Approved Vendor files, Product dossier files
Responsible for investigation of market complaint, deviation, change control, incidence, returned goods, product recall.
Supervise all QMS documentation issuance/ distribution, retrieval and destruction
Preparation of Self- inspection plan, Site master file, Validation master plan, Safety Manual, Quality manual, water manual
Prepare and review Annual Product Quality Report (APQR)
Prepare and check SOP's
Monitoring of training activity in entire plant as per scheduler.
