Job Description

Hello, Greetings for day! Please find the below JD Preparation/ review of standard operating procedure (SOP), calibration procedures, specifications, standard test procedures, general test procedures etc. Conducting training on specification and method of analysis, SOPS and calibration procedures. Handling of QMS documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To ensure timely closure of documents like Change control, CAPA, Incidents, OOS, deviations, Out of calibrations, OOT etc. To investigate the laboratory error / incident and its impact on quality and analysis of all samples. Participating as a cross functional team member for investigation of any QMS related issues. To observe and maintain Good Laboratory Practices. To prepare / review documents like stability schedule, hold time study schedule, preventive maintenance schedule, calibration schedule. Co-ordination with outside calibration agencies. To prepare/review instrument qualification data. Coordinating with other departments for smooth functioning of laboratory. Arranging standards required for the analysis. Arranging columns required for analysis. To approved sign in TRF( Intermediate) ,GRN,Hold time sample, stability sample Ensuring training of departmental staffs as per job requirement. Attending training program as per CGMP training schedule. To take part in method validation/transfer/verification activity. To maintain discipline in the laboratory. To prepare the analysis request form and send the sample to contract laboratory for analysis. To take part in customer/regulatory/internal audits. Responsible for follow the health, safety & environment norms as per company policy & procedures. To monitor the good housekeeping practices in all quality control area. To co-operate in achieving the quality control objective. Preferred candidates should be form CDMO industry or somebody who has handled multiple API product and handled 50 members team. Interested candidates can share their update resume and below details on 'jyotsna.sable@aartipharmalabs.com' Total years of exp: Current CTC Exp CTC: Notice Period: Are you open for move to Gujarat: Do you have experience in CDMO/API Manufacturing Industry: what is the team size did you handle?