Quality Assurance Head

Job Description

Quality Assurance Head reports to Director. He has the responsibility and authority for: · To implement the proper documentation control system. · To approve the SOPs, MFR, BMR, Specification, APQR , Validation protocols & reports etc. · To approve / reject Raw material, Packing material, Bulk & Finished product. · To approve / reject the Planned Deviation & Change Control. · To monitor the Unplanned Deviation. · To implement the calibration program with the help of the head of all departments. · To implement the validation activity ( which contains Qualification of Equipment/ Instrument, Process validation, Cleaning validation & Analytical Method validation ) with the help of the respective department head. · To perform BMR review, In-process & Analytical report review & Batch Release. · To perform the investigation of Out of Specification & Out of Trend with the help of Quality Control department. · To monitor the Stability study of the product. · Vendor approval with the help of Quality control, Store & Purchase. · To attend the market complaints, carry out the investigation & if required co-ordinate for the recall with the help of management. If no recall, then satisfactory feedback is given to Customer on investigation basis & the record of the same is maintained. · Carry out the Self Inspection with the help of the Self inspection team & provide the appropriate feed back to management of the GMP status of the company, take corrective & preventive actions to repair the deficiencs on timely basis. · To perform the Gap analysis & Risk analysis with the help of the all department heads & try to nullify the gap & risk by taking appropriate measures. · To implement the training program with the help of the management & Head of all the departments & maintain their records. · The monitoring and control of the manufacturing environment. · Plant hygiene. · The retention of records. · The monitoring of compliance with GMP requirements. Job Type: Full-time Pay: ₹250,000.00 - ₹600,000.00 per year Schedule: Day shift Supplemental Pay: Yearly bonus Location: Palghar, Maharashtra (Required) Work Location: In person