Mannem Bhaskar Reddy

About 22+ years experience in Quality Control Department.

Head Quality Control - BIOCON Limited, Mfg.Division, Hyderabad - Hyderabad

(2025-09)

• Ensuring the Approval/Rejection of Raw material, Intermediates and Finished products as per production schedule.
• Monitoring a team of QC Managers, supervisors and the laboratory teams to ensure that analytical testing, data review activities and Laboratory equipment and systems on site comply with site Standard Operating Procedures.
• Responsible for developing and managing integrated Quality Systems and providing technical support and advising on Quality Control matters to other areas within the site.
• Responsible for setting up and implementing QC Laboratory quality systems.
• Review and approval of Standard Operating Procedures (SOPs) and periodic review processes.
• Responsible for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
• Planning and tracking Quality Control objectives, timelines, priorities, and resources.
• Managing and ensuring the provision of chemical and microbiological analytical services to internal or external customers to ensure that all starting materials, water samples, intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements, to provide accurate test results for correct GMP usage decisions.
• Preparing the budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
• Ensuring a safe working environment for the laboratory. Taking initiatives to improve safety performance and employee engagement. Performing investigation related to EHS as required.
• Ensuring that the laboratory equipments are qualified to meet regulatory standards, well maintained and in good working order.
• Working closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
• Ensuring the process validation and cleaning validations samples to be completed as per production schedule plan.
• Planning of Analytical Method transfers, method validations & Method Verifications.
• Promoting use of Right First Time (RFT) methodologies and root cause analysis tools for analytical troubleshooting and Continuous Improvement Projects.
• Ensuring the product stability programs are managed and testing data is reported for Annual Product Review Reports and regulatory filing in a timely manner.
• Developing and motivating staff to help realize their maximum potential to contribute towards achieving the site objectives.
• Handling customer complaints, OOS, OOT and Incidents and ensuring the timely closure of investigation as per timelines.
• Monitoring of Pharmacopoeial updates and initiation of Pharmacopoeial evaluations and implementation.
• Handling of Quality Control regulatory Audits and its compliance.
• Prepare and review of audit response and customer complaint reports.
• Provided analytical support for regulatory and DMF quarries.
• Preparation of Monthly Reports to present senior management.
• Ensuring the all quality control instruments calibration and their preventive maintenance are performed as per schedule without deviations.

Head Quality Control-Deputy General Manager - HONOUR LAB PVT LTD, Mfg.Division, Hyderabad - Hyderabad

(2020-04 - 2025-09)

• Ensuring the Approval/Rejection of Raw material, Intermediates and Finished products as per production schedule.
• Monitoring a team of QC Managers, supervisors and the laboratory teams to ensure that analytical testing, data review activities and Laboratory equipment and systems on site comply with site Standard Operating Procedures.
• Responsible for developing and managing integrated Quality Systems and providing technical support and advising on Quality Control matters to other areas within the site.
• Responsible for setting up and implementing QC Laboratory quality systems.
• Review and approval of Standard Operating Procedures (SOPs) and periodic review processes.
• Responsible for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
• Managing and ensuring the provision of chemical and microbiological analytical services to internal or external customers to ensure that all starting materials, water samples, intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements, to provide accurate test results for correct GMP usage decisions.
• Preparing the budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
• Working closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
• Ensuring the process validation and cleaning validations samples to be completed as per production schedule plan.
• Planning of Analytical Method transfers, method validations & Method Verifications.
• Promoting use of Right First Time (RFT) methodologies and root cause analysis tools for analytical troubleshooting and Continuous Improvement Projects.
• Ensuring the product stability programs are managed and testing data is reported for Annual Product Review Reports and regulatory filing in a timely manner.
• Handling customer complaints, OOS, OOT and Incidents and ensuring the timely closure of investigation as per timelines.
• Monitoring of Pharmacopoeial updates and initiation of Pharmacopoeial evaluations and implementation.

Quality Control Senior Manager - Dr REDDYS LABS PVT LTD, Mfg.Division, unit-3, Hyderabad - Hyderabad

(2015-11 - 2020-04)

• Ensuring the Approval/Rejection of Raw material, Intermediates and Finished products.
• Review of the routine work plan of the team leaders and teams and ensure appropriate instrument utilization.
• Responsible for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
• Developing and motivating staff to help realize their maximum potential to contribute towards achieving the site objectives.
• Preparing the budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
• Handling customer complaints, OOS, OOT and Incidents.
• Monitoring of Daily Quality control release activities.
• Ensuring the data compliance through LIMS / SAP and Empower software.
• Planning of Analytical method validations & Method Verifications.
• Coordinating with internal customers like production, ware-house and quality assurance for uninterrupted release of raw materials, intermediates and Finished products.
• Monitoring of Pharmacopoeial updates and initiation of Pharmacopoeial evaluations.
• Updation of pharmacopoeial changes in the respective Specifications.
• Planning of Stability Analysis as per schedule.
• Planning of Analytical method transfers.
• Review of the Analytical method issues.
• Simplification Quality Control procedures.
• Implementation of new Quality Control procedures.
• Harmonization of all Quality Control procedures.
• Quality Control Audit compliance.
• Provided analytical support for regulatory and DMF quarries.
• Preparation of Monthly Reports.
• Troubleshooting of Instruments, Calibration of instruments and their preventive maintenance.
• Inspection, investigation and analysis of samples, to monitor quality of product.

CQC Manager - HETERO DRUGS PVT LTD - Hyderabad

(2015-03 - 2015-11)

• Review of Analytical method validations & Method Verifications.
• Review of the Analytical method issues and Discussion with AR&D with same and rectification and implementation of rectified methods.
• Review of all Quality control procedures.
• Simplification Quality Control procedures.
• Implementation of new Quality Control procedures.
• Harmonization of all Quality Control procedures.
• Quality Control Audit compliance.
• Performing internal Quality Control audits.
• Provided analytical support for regulatory and DMF quarries.
• Analytical method transfers.
• Review of Monthly Reports to present senior management.
• Troubleshooting of Instruments, Calibration of instruments and their preventive maintenance.
• Discussion of OOS laboratory results with the Dept. Head, initiation of investigation of such results.
• Inspection, investigation and analysis of samples, to monitor quality of product.
• Planning of Stability Analysis as per schedule.
• Monitoring of Daily Quality control release activities.
• Monitoring of Pharmacopoeial updates and initiation of Pharmacopoeial evaluations.
• Updation of pharmacopoeial changes in the respective Specifications.
• Investigation of customer complaints.

API & Formulation Analytical Division - NOVARTIS HEALTHCARE PVT LTD - Hyderabad

(2013-01 - 2015-03)

• Planning of Analytical method validations & Method Transfer by HPLC.
• Planning of Analytical method validations & Method Transfer by GC.
• Review of the Analytical method validation Reports.
• Performed Forced degradation Studies to identify the possible route of degradation and Stability indicative methods.
• Provided analytical support for regulatory and DMF quarries related to API Finished Products.
• Troubleshooting of Instruments, Calibration of instruments and their preventive maintenance.
• Daily allocation of work to the analyst and review of work output report and pending work.
• Discussion of OOS laboratory results with the Dept. Head, initiation of investigation of such results and submission of additional results.
• Inspection, investigation and analysis of samples, to monitor quality of product.
• Planning of Stability Analysis as per schedule.
• Preparation & Approving of Stability protocols.
• Preparation of Stability summaries.
• Monitoring and planning of Daily release activities.
• Audit compliance.

Quality Control Section Head - CIPLA LTD,unit-1, API & Formulation Mfg. Division - Bangalore-049

(2006-07 - 2013-01)

6.6 Years

• Daily allocation of work to the analyst and review of work output report and pending work.
• Checking of report of the analyst against standards and submission of checked reports to the Head Quality control.
• Co-ordinating with production dept. for priorities and urgencies.
• Responsible for regular sampling and testing, it includes on-line Quality control, Intermediates and in-process controls along with production. Provides technical support and training to QC personnel.
• Review and Approval of Raw material, Intermediates and Finished products data.
• Timely reporting of results of testing to facilitate the achievement of production schedules.
• Discussion of OOS / OOT laboratory results with the Dept. Head, initiation of investigation of such results and submission of additional results.
• Inspection, investigation and analysis of samples, to monitor quality of product.
• Planning of Stability Analysis as per schedule.
• Preparation & Approving of Stability protocols.
• Preparation of Stability summaries.
• Planning of Analytical method validations & Method Transfers by HPLC.
• Planning of Analytical method validations & Method Transfers by GC.
• Review of the Analytical method validation Reports.
• Performed Forced degradation Studies to identify the possible route of degradation and Stability indicative methods.
• Provided analytical support for regulatory and DMF quarries related to API's & Formulation Products.
• Ensuring the Approval/Rejection of Raw material, Intermediates and Finished products.
• Preparing trend analysis report of intermediates and API Finished Products.
• Planning Process validation analysis & Cleaning validations.
• Troubleshooting of Instruments, Calibration of instruments and their preventive maintenance.
• Pharmacopoeia Method verifications and partial validations and analysis where regulatory requires to fulfill the queries & Deficiency's.
• Preparation of required documents for all Audits and Audits compliance.

QC- Chemist - AUROBINDO PHARMA LTD .UNIT-I, Mfg Division

(2004-08 - 2006-07)

about 2 years

• Sampling and Analysis of Finished products, Intermediates and Raw Materials.
• Calibration & Performance check of all Laboratories Analytical Instruments.
• Analysis of RM, Intermediates and Finished products by HPLC.
• Analysis of RM, Intermediates and Finished products by GC.
• Analysis of RM, Intermediates and Finished products at Wet Analytical Laboratory.
• Responsible for the maintenance of QC Records and other QC activities.
• Planning of analysis against Dispatch.
• In-process controls and line clearance for manufacturing and packing.

M.Sc - Organic Chemistry - Kakatiya University (2002 - 2004)

B.Sc - Osmania University