Posted:1 week ago|
Platform:
Work from Office
Full Time
Preparing and reviewing of written procedures (MFR, BPR, ECR, SOP) for the production of intermediates or APIs as per laid down quality system standards & pre- approved documents.
Production of API and intermediates according to approved BPR.
Ensuring the cleaning of equipment and production facility according to approved ECR.
Evaluation of changes in process, equipment and facilities for impact on product quality.
Review of batch production record & cleaning records and ensuring that these are completed and signed.
Preparation and review of qualification protocol & report.
Review of validation protocol & report, and quality system documents and records.
Perform the necessary calibration and qualification activity for equipment, facilities and maintaining the records.
Ensuring the production facility and equipments are clean and appropriate disinfected.
Report and investigation the deviations, nonconformity with appropriate CAPA.
Carry out the investigation for nonconformity like deviation, OOS, OOT, complaint, breakdown etc.
Initiate of corrective and preventive action as and when required.
Ensure that the processes are carried out in an effective manner so as to ensure expected output is achieved.
Implementation of technology transfer for new products.
Implementation of quality management system and SOPs.
Ensure GMP, good housekeeping and safety in manufacturing area.
Controlling and monitoring the quality of products.
Controlling and monitoring on inventory.
Monitor the compliance for internal and external audit observations.
Indoco Remedies
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