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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | uality (QA-QC) |
| EmploymentType | Full-time |
We have opening in Quality Assurance MANAGER . in Tarapur / Palghar Location API Plant for Pharma Industry.Qualification- B.Sc / M.ScExperience: 10 to 20 yearsCTC Range - 16 LacCompany Will be API USDFA APPROVEDInterested candidate mail your resume on sevalal777@yahoo.comJD:Ensure quality standards for all products and manufacturing activitiesTo organize, educate for and execute activity as per the norms of Quality Assurance objective.Approving changes that potentially impact intermediate or API quality and responsible for final authorization of change control.Releasing or rejecting intermediates for use outside the control of the manufacturing company; raw materials, intermediates, packaging and labeling materials.Responsible for authorization of process validation protocol and report.Responsible for executing cleaning validation as per protocol and authorizing cleaning validation protocol and report.Provide compliance to customer complaints by coordination with marketing department.Releasing or rejecting APIs and Intermediates. Releasing or rejecting intermediates for use outside the control of manufacturing company.Establishing the system to release or reject raw material, intermediate, packing and labeling materials.Implementation of stability studies programme of finished products and intermediate to support retest or expiry dates and storage condition.To ensure all equipments require for Quality Control testing, are calibrated and maintained in good condition as per SOP.Establishing the system to execute analytical method validation as per the protocolEnsure that the work force is highly motivated and aligned to the Company objectivesArrange effective training to all employee on cGMP and Good documentation practices.To report higher management for effective implementation of GMP activities.To communicate external customers with respect to product quality and audit compliances.To ensure customer satisfaction in timely manner and as per requirement.To identify training need of all employees with the help of HOD.To prepare annual training calendar in consultation with HR and HOD.To plan training on weekly/ fortnightly/ monthly basis to comply the training calendar/schedule.To give training to concerned employees on Good manufacturing practices, Good laboratory practices and Good documentation practices.To give training to all concerned employees on GMP/GLP and as per current guidelines.To conduct all training with feedback and assessment evaluation system.To prepare SOP on product stewardshipTo prepare SOP on raw material receipt, analysis, unloading and inspection of tanker / truck/ container coming for Finished Goods loadingTo prepare inspection list for the inspection of tanker/ lorry as per Central Motor Vehicle ruleEnsure that all the required SOPs are in place with identifying all environmental aspects.To ensure record history of all past activities and document.To ensure all the compliances of inspections of facilities including internal and external customers.Inspect all facilities (cross functional) by using prescribed format.Before you come contact on below no for interview schedule9561260777/ 8149881777 / 8793920777E/002 Ground Floor ,Krisha Apt.BuldgNo.-10 Yashwant Srushti,Back Side SaiBaba Temple,Boisar Palghar Road,Boisar (W).8087652777/8983655777/8983920777Please enroll here : http://www.sevalalplacement.com/new_registration.aspx