Overall in-charge and responsible for all operations having an impact on qualify of the process and final product.
Responsible for Implementation of GMP
Responsible for the Implementation of good housekeeping and plan1 hygiene policy.
Responsible for the final approval all the product for dispatch after reviewing all the quality records. (Batch Manufacturing and packing Records, In-process Quality Control records, COAS, and other related batch records like deviation/investigation reports).
Responsible for the coordination of the cGMP and on the job training of the plant personnel,
Responsible for initiation, review and assessment of investigations and approval of deviation in process.
Responsible for the approval of the standard operating procedures, standard testing procedures, General Testing Procedures , Validation protocols, Master Formula Records, batch records (UMR,/BPK] and all other master documents.
Responsible for total documentation control through) proper change control system.
Responsible for the validation of the process/facility.
Responsible for the review and Investigation of market complaints.
Responsible for the coordination incase of product recalls.
Responsible for the EMP monitoring in the plant by conducting internal audits.
Responsible for the Timely updation of the documents online with the current regulatory guidelines.
Responsible for monitoring the operations of the contract manufacturing.
Responsible for the qualification studies of equipment,
Responsible for the approval of the Site Master File and Validation Master Plan.
Responsible for authorization of artwork.
Periodic assessment of the vendors through conducting vendor audit and vendor approval,
Responsible for the assessment of non-conformance and final approval for disposition,
To approve the external agencies carrying out the calibration and annual maintenance services.
Responsible for training of plant personnel.
To perform the annual product quality reviews.
To ensure availability of adequate resources required for QA department,
Responsible for handling of Out of Specifications results.
Candidate must have experience in pharma ( formulation unit,Oncology, injectables and Steroids)