Manager - API

As the Manager - API at Dishman Carbogen Amcis Limited, located in Bavla, Gujarat, IN, your role involves the following responsibilities: - Preparation and review of Standard Operating Procedures. - Issuance, review of OOS, OOT, Deviation, CAPA, Change Control & its Management. - Handling and monitoring of control samples. - Imparting internal trainings to DCAL Employees. - Reviewing Calibration records, Instrument Logs of Quality Control. - Reviewing Analytical Method Validation protocols and reports. - Reviewing the Instrument qualifications and re-qualifications protocols of Quality control. - Preparation and review of quality risk assessment documents. - Reviewing and approving analytical data related to QA release. - Reviewing and approving Specification STP, Raw data sheet etc. - Reviewing laboratory investigations related to complaints and deviations and ensuring CAPA related to QC are completed within the timeline. - Ensuring Internal Audit and External audit Compliance. - Supporting RA for analytical assistance. - Reviewing working standard management and Stability studies. - Handling customer complaints, OOS, OOT, Incidents, Deviation & CAPA. - Taking responsibility for and participating in the review of OOS Investigation, Deviation, Complaint Investigation. - Carrying out any job assigned by Immediate Supervisor/HOD based on training. - Maintaining safety, health, and environment norms and using personal protective equipment during work. Additionally, you will be involved in various quality control, internal audit, CAPA, laboratory, and QA activities within the company. (Note: No additional company details were provided in the job description.),