Analyst QC

• B. Pharmacy/M. Pharmacy (Pharmaceutical Analysis and Quality Assurance)/ M. Sc.in chemistry or Equivalent
• 5 to 8 years in formulation pharmaceutical industries in quality control Department.
• Responsible for handling day-to-day activities and ensuring the completion of tasks related to sampling, testing, and release of active ingredients, inactive ingredients, packaging materials, in-process and finished products, stability samples.
• To ensure that all activities carried out within the respective section of the quality control meet the current applicable cGMP guidelines, and regulatory expectations.
• Responsible for ensuring timely sampling, analysis, and release of materials intended for use in the manufacturing of products.
• Responsible for timely completion of qualifications and release of equipment’s or Instruments for the usage.
• Responsible for Analyst qualifications and maintenance of the relevant records.
• Ensure proper implementation and to follow the hygiene SOP within the QC and Microbiology areas.
• Responsible for Analyst qualifications and maintenance of the relevant records.
• Ensure proper implementation and to follow the hygiene SOP within the QC and Microbiology areas.
• Ensure proper implementation of the SOP for equipment or Instrument operation, cleaning, and maintenance within the QC and to follow implemented procedures.
• Responsible for ensuring cGMP, GLP within the QC.
• Responsible for intimating any breakdowns to the next level personnel.
• Ensure to implement the Good Document practices SOP within the QC.
• Responsible for preparation/ review of Protocols and other cGMP documents.
• Implementation of Quality systems in QC.
• Responsible for following quality systems developed within the site.
• Initiation, review of Change controls, Deviations, CAPA, OOS and OOL reports.
• Participation in the investigation and preparation and review of Investigation reports if any.
• Responsible for review of method verification/ validation, cleaning validation/ verification protocols and reports.
• Responsible for monitoring the equipment/instrument qualification, Process validation, cleaning validation related activities in QC.
• Responsible for involving and reviewing the qualification protocols related to QC equipment, utilities, instruments, or systems.
• Responsible to ensure that all the systems Facility / Utility / Equipment / System / Instrument within the QC are in a valid state on daily basis.
• Ensure that all the Preventive maintenance of instruments/ equipment’s in QC were performed within the due period as per the schedule.
• Ensure that all the instruments were in calibrated state as per the calibration schedules.
• Responsible for performing calibrations, as necessary.
• Responsible for planning and control of reference standards, Columns, Glassware, and other chemicals required for sample analysis in QC.
• Responsible for investigating any Events/deviations occurred in QC.
• Investigate the Out of specifications/Out of trends during the analysis.
• Responsible for review, revise, maintain the QC SOPs as and when required.
• Responsible for ensuring the implementation of the CAPA incase of any deviations/Events/Change control/OOT/OOS.
• Responsible for maintaining reserve and regular samples, as well as standards, chemicals consumption, utilization, and stock records.
• Preparation and Approval of Job descriptions of repartees.

Location:Ferring India Laboratories