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.
