Quality Assurance Manager -FDA Approved

Role & responsibilities

• Check all SOPs of QC available
• Check the record of cleanliness of the area.
• Check the list of instrument/equipment update
• Check that activities like sampling, testing and handling of special chemicals are done by taking proper precautions.
• Check that labeling are done on samples withdrawn and after passing.
• Check standardization of reagent/solution and labeling.
• Check whether signed specification and method of analysis are available.
• Check the calibration record of instrument/equipment.
• Check the calibration chart for all instrument/equipment.
• Check all the analyst qualified and record available.
• Check the stability sample against stability schedule.
• Check the stability record against stability program.
• Check whether water sampling is done as per sampling plan.
• Check the analysis record of water for chemical and microbial tests.
• Check the record of standardization of volumetric solution.
• Check the sample entry register and ensure sampling is done as per sampling plan.
• Check any analysis record to ensure that analysis is done as per specification and test procedures are strictly followed.
• Check approved vendor list available and updated.
• Check number of out of specification since last audit.
• Check and issue of BMR/BPR.
• Check the medical examination report.
• Check the record for cleaning of water tank.
• Check entry and exit of personnels and visitors record.
• Check and keep pest control record.
• Taking approval for new product and made necessary document.
• Keep track on training record (in house /external).
• Vendor audits
• Keep the record of hazardous material.
• Prepare new BMR for new product.
• Keep the inventory for glassware and chemicals.
• Keep the record for finished goods.
• Check the storage condition for raw materials and finished goods.
• Keep the record of stereo control.
• Check the status labeling.
• Keep the log book for instrument.
• Area monitoring and pressure differentials.
• Monitoring of quality of water.
• Maintain the record of preventive maintenance.
• Keep the record of calibration and validation method.
• Keep the record of stability studies, Change control, Deviation, MFR’s.
• Maintenance of working standards.
• Records of control sample.
• As on when Management Assigned any Job.
• Dispensing/checking of dispensed RM/PM.
• Process validation.
• Regulatory affairs.
• Preparation of SOPs
• QC related routine activities(periodic checking of QC reports and records)
• MFR writing and BMR management.
• Documentation control.
• Complaint handling.
• Face FDA inspection, ISO audit, outside party inspection.
• Face Internal audit.
• Worked as chemist in QC lab handling all day-to-day work. Familiar with IP BP & USP
• Methods of analysis. Analysis of raw material & finished products having experience in good laboratory practices. Made GLP By control Charts & In
• House QC samples & Standards
• Participated in round robin analysis with different laboratories like shell & sabic
• Familiar With ASTM, UOP & IP methods of testing
• Actively Participated in Interview Recruitment of new Chemist
• Having excellent safety and attendance record.
• Authorized For IATA to sent samples & Dangerous Goods by air
• Made Laboratory Hygiene plan & Quality Check Plan
• Review and approval of Laboratory investigations.
• Review and approval of investigations related to deviation and market complaint.
• Review and approval of CAPA proposals.
• Review and approval of change controls.
• Evaluating trends of Deviations, Complaints and OOS, proposing CAPAs based on evaluation and assuring implementation of the same.
• Participation in Regulatory inspections, compiling inspectional responses and monitoring compliance.
• Annual product quality review.
• Vendor Management
• Conducting internal audits.
• Conducting weekly meetings of Quality functions.
• Participating in Management Review Meets.
• Conducting training on ‘QMS related procedures’, ‘Conduct during inspections’, ‘Effective review practices’, ‘Data integrity’ etc.
• Review of change controls, investigation of Deviation & Laboratory Investigations.
• Investigations of market complaints, Root cause analysis & implementation of CAPA.
• Evaluating trends of Deviations, Complaints and OOS, proposing CAPAs based on evaluation and assuring implementation of the same.
• Preparation & revision of Site master File, Validation Master Plan and QMS SOPs.
• Preparation for Regulatory inspections, compiling inspectional responses and monitoring compliance.
• Communication with clients related to investigations/ inspectional compliance.
• CAPA effectiveness verification.
• Review and monitoring of cleaning validation program.
• Participating in self-inspection program.
• Preparation & Participating in Management Review Meets.
• Review of risk assessment of various functions.
• Conducting training on ‘cGMP’, ‘QMS related procedures’, etc.

Monthly Auditor for lab

Preferred candidate profile

Perks and benefits