Senior Manager Qualiy Control
S.J. & G Fazul Ellahie Pvt Ltd
Total des années d'expérience :15 years, 1 Mois
Ensure timely development of new products test method as per launch plan of Business Development.
• Lead & Manage the Analytical Testing of existing API, Excipients & Packaging Material as well as for New Vendor approval.
• Lead & Manage the Method Development, Analytical Method Validation/Verification, CDP & SFG Testing.
• Lead and manage the requirements of ISO/IEC 17025.
• Ensures smooth functioning of QC Lab instruments through: Planned preventive maintenance, Periodic calibration of equipment & Proper documentation and sufficient availability of spares.
• Lead & Manage Stability Program for New Products as well as Commercial Products.
• Ensure successful TAP for new Testing methods to Q.C Finished Product Section.
• Ensure submission of related documents to RA for Local & International submission.
• Review Pharmacopeia/In-House developed testing methods, reports of RM, SFG and Stability reports and protocols.
• Lead & Manage all staff reporting, train, evaluates, motivate, delegate and monitor their activities.
• Provide assistance to GM QO in departmental CAPEX & budget planning.
• Lead & Manage all activities in QC & SAS Department, and responsible for smooth working.
• Ensure timely development of new products as per launch plan of Business Development.
• Ensures smooth functioning of QC & SAS Lab instruments through: Planned preventive maintenance, Periodic calibration of equipment & Proper documentation and sufficient availability of spares.
• Lead & Manage stability program for New Products as well as Commercial Products.
• Ensure successfully technology transfer of new Testing methods to Q.C.
• Ensure submission of related documents to RA for Local & International submission.
• Review Pharmacopeia/In-House developed testing methods, reports of API, SFG and Stability reports and protocols.
• Lead & Manage all staff reporting, train, evaluates, motivate, delegate and monitor their activities.
• Provide assistance to Head QO in departmental CAPEX & budget planning.
• Perform any other duties as assigned by Head QO.
• Lead & Manage all activities in Quality Control Department, and responsible for smooth working.
• Ensure timely development of new products as per launch plan of Business Development.
• Ensures smooth functioning of QC instruments through: Planned preventive maintenance, Periodic calibration of equipment & Proper documentation and sufficient availability of spares.
• Lead & Manage stability program for New Products as well as Commercial Products.
• Ensure successfully technology transfer of new Testing methods to QC Finished Product section.
• Ensure submission of related documents to RA for Local & International submission.
• Review Pharmacopeia/In-House developed testing methods, reports of API, SFG and Stability reports and protocols.
• Lead & Manage all staff reporting, train, evaluates, motivate, delegate and monitor their activities.
• Provide assistance to Head of QO in departmental CAPEX & budget planning.
• Perform any other duties as assigned by Head of QO.
Ensure timely development of new products test method as per launch plan of Business Development.
• Lead & Manage the Analytical Testing of new API and Vendor approval
• Lead & Manage the Method Development, CDP, validation & SFG Testing.
• Ensures smooth functioning of AS Lab instruments through: Planned preventive maintenance, Periodic calibration of equipment & Proper documentation and sufficient availability of spares.
• Lead & Manage stability program for New Products as well as Commercial Products.
• Ensure successfully technology transfer of new Testing methods to Q.C.
• Ensure submission of related documents to RA for Local & International submission.
• Review Pharmacopeia/In-House developed testing methods, reports of API, SFG and Stability reports and protocols.
• Lead & Manage all staff reporting, train, evaluates, motivate, delegate and monitor their activities.
• Provide assistance to GM QO in departmental CAPEX & budget planning.
• Perform any other duties as assigned by Director QO.
Ensure timely development of new products test method as per launch plan of Business Development.
• Lead & Manage the Analytical Testing of new API and Vendor approval
• Lead & Manage the Method Development, CDP, validation & SFG Testing.
• Ensures smooth functioning of AS Lab instruments through: Planned preventive maintenance, Periodic calibration of equipment & Proper documentation and sufficient availability of spares.
• Lead & Manage stability program for New Products as well as Commercial Products.
• Ensure successfully technology transfer of new Testing methods to Q.C.
• Ensure submission of related documents to RA for Local & International submission.
• Review Pharmacopeia/In-House developed testing methods, reports of API, SFG and Stability reports and protocols.
• Lead & Manage all staff reporting, train, evaluates, motivate, delegate and monitor their activities.
• Provide assistance to GM QO in departmental CAPEX & budget planning.
• Perform any other duties as assigned by GM QO.
* Look after all activities in QC Department, and responsible for smooth working of the department.
* Complete command on the handling of more advanced instruments, such as HPLC/HPTLC/GC/IR, automated dissolution apparatus etc and their techniques.
* Handling of all Export queries and complains related to QC.
* Well versed from the stability studies of Raw materials as well as finished products. * Experienced in analysis of samples, using compendia (USP/BP/EP) and/or manufacturer’s method.
* Command on method validation techniques and criteria for method acceptance.
* Can develop new methods or revise existing method and validate the method so developed.
* Participate in collaborative studies at inter- or intra-laboratory level.
* Preventive maintenance, calibration of instruments with documentation.
* Support Manager in day to day activities.
* Train new chemist on procedures and practices.
• To perform testing of samples of finished product and carryover stock.
• To perform testing of raw material samples.
• To perform testing of packaging material samples.
• To perform testing of complaint samples & sample for approval.
• In-process checks of production & sampling from store.
• Artwork checking & maintain record via artwork tracking sheets.
• Maintain record of analytical standard received from Bayer AG.
• Follow & revise SOP’s and QC specifications.
• Preventive maintenance, calibration of instruments with documentation.
• Active participation in new packaging development process.
• To ensure retention of lab reference samples of all batches of all products.
• Housekeeping of laboratory.
1. To perform testing of samples of semi-finished and finished products.
·2 Method development of new products.
·3 Validation of testing methods of finished products.
·4 To perform testing of raw material samples.
·5 Stability testing of finished products.
·6 To perform testing of all types of waters .
·7 To perform in-house calibration of instruments.
·8 Preparation of lab reagents and standardized volumetric solutions.
·9 Follow & revise SOP’s and QC specifications .
·10 Support QCM in day to day activities.
·11 Management of QC consumables .
·12 Train new chemist on procedures and practices
. To perform testing of samples of SEMI-FINISHED AND FINISHED PRODUCTS.
. Method development of new products.
. Stability testing of finished products.
. To perform testing of all types of waters a/c to USP.
. Sampling of finished and semi-finished products.
. To perform testing of raw material samples.
. In-house calibration of equipments including balances as per schedule
• Testing of Raw materials, finished and semi-finished products on HPLC and spectrophotometer.
• Monitoring dispensing of raw materials according to batch requirement.
• Perform in-process of different manufacturing processes.
• In house calibration of equipments as per schedule and keep their records maintained.
