Duty Manager in Quality Control Department leading day-to-day quality control work for incoming materials, intermediates, raw materials, and finished products in an API manufacturing setting. Directs LIMS master data, sample management, and data upload teams while handling OOS, OOT, and incident investigations. Supports cGMP training, LIMS validation, and regulatory audits across USFDA, PMDA, EDQM, and EU inspections.
Hi, I’m
Dharma Reddy
MIYAPUR
Summary
Overview
1
Language
20
years of professional experience
Work History
M/s. MSN Life Science Private Limited
Duty Manager in Quality Control Department
09.2022 - Current
Job overview
- Present working as a Duty Manager in Quality Control Department in M/s. MSN Life Science Private Limited., Unit-II, (API-Division), Hyderabad from September-2022 to till date.
- 19 years+ of Quality Control working experience in the field of Pharmaceutical.
- Managed all day-to-day quality control activities, including planning, analysis, and execution of incoming materials, finished products, intermediates, and raw materials.
- To monitor the LIMS Mater Team & Data uploading Team. (Empower to LIMS through interphase)
- Responsible for handling of investigation systems like OOS, OOT, and Incidents.
- To provide the Training programs for cGMP practices and on-job training to Quality control.
- Validated LIMS software through IQ, OQ, and PQ during various qualifications and troubleshooting processes.
- Responsible for Implementation of Caliber LIMS Version: 3.6.0.E (Laboratory Information Management System) in Quality Control at MSN Laboratories Life Science Private Limited Unit-II, For Sample Manager and Resource Manager.
- QMS Activities like OOC,OOS,OOT& Incident Managements also implemented in LIMS.
- Participated in regulatory and customer audits, including USFDA, PMDA, EDQM, and EU.
- Experience Details: 19 Years+
M/s. Aurobindo Pharma Ltd.
Sr. Executive (E4) in Corporate Quality Control Department
08.2017 - 08.2022
Job overview
- Worked as a Sr. Executive (E4) in Corporate Quality Control Department in M/s. Aurobindo Pharma Ltd., HO (API-Division), Hyderabad from August-2017 to August-2022.
- Implemented Caliber LIMS Version: 3.3.0.E (Laboratory Information Management System) in Quality Control at Aurobindo Pharma Ltd.
- To eligible trained various modules (Sample Manager (Masters & Plant), Resource modules and System Manager) others and also to carry out Validation activities for any updations (patches) in Caliber LIMS 3.3.0E version.
- Actively involved in the Validation of LIMS software IQ, OQ and PQ during various Qualification.
- Training of personnel for smooth operation of LIMS in Quality control laboratories.
- Responsible for creation of master’s Data in LIMS for all the Modules (Sample Manager, Resource Manager and System Manager) in line with regulatory requirements.
- Preparation of LIMS SOP’s, test scripts, protocols, reports and all such other documents at various phases of LIMS qualification and implementation.
- Corporate Quality Control Department in Laboratory Information Management System (LIMS)
M/s. Aurobindo Pharma Ltd.
Sr. Executive (E3) in Quality Control Department
01.2013 - 08.2017
Job overview
- Worked as a Sr. Executive (E3) in Quality Control Department in M/s. Aurobindo Pharma Ltd., Unit-I (API-Division), Hyderabad from January-2013 to August-2017.
- Responsible for all day to day quality control activities like planning, analysis and execution of various incoming materials as finished products.
- Responsible for handling of investigation systems like OOS, OOT, and Incidents.
- Responsible for following the Good laboratory procedures.
- Knowledge about management of working standard and reference standard management.
- Comprehensive knowledge about Empower 3 CDS software.
- Comprehensive knowledge about data integrity guidelines as per USFDA and MHRA guidelines.
- Comprehensive knowledge about management of reserve/retention samples management.
- Perform all work in compliance with current SOPs, GLP, GMP and safety requirements.
- HPLC API Section In charge
M/s. Inogent Laboratories Ltd.
Executive in Quality Control Department
04.2009 - 01.2013
Job overview
- Worked as a Executive in Quality Control Department in M/s. Inogent Laboratories Ltd. (A GVK Bio Group Company), Hyderabad from April-2009 to January-2013.
- Responsible for all day to day quality control activities like planning, analysis and execution of various incoming materials like inprocess, intermediates, raw materials and finished products.
- Played instrumental role in the Review and Analysis of Active Pharmaceutical ingredients, materials and intermediates by using analytical instruments like, HPLC, GC, FTIR, UV/ VIS, and Autotitrator.
- Maintaining and review documentation such as laboratory notebooks, electronic data collection/storage software, instrument logbooks, training records, etc.
- Ensure compliance of various quality measures such as GLP by maintenance of appropriate requisite documentation/ records.
- (A GVK Bio Group Company)
- A GVK Bio Group Company
M/s. Gulf Oil Corporation Ltd.
Chemist in Quality Control Department
10.2006 - 04.2009
Job overview
- Worked as a Chemist in Quality Control Department in M/s. Gulf Oil Corporation Ltd., Hyderabad from October-2006 to April-2009.
- Analysis of In process Samples Recovered Solvents Wet analysis like LOD, Sulphated ash, Water content, Reaction Mass by HPLC and GC.
- Preparation of Volumetric solutions and Buffer solutions.
- Maintained the Laboratory notebooks, instrument logbooks, training records online.
- To following the current SOPs, GLP and GMP practices.
Education
Bharathidasan UniversityTiruchi
M.Sc. from Bio-Technology
01-2004
University Overview
Sri Venkateswara UniversityTirupathi
B.Sc.
01-2002
University Overview
Skills
OOS investigation
OOT investigation
Incident management
GMP compliance
Data integrity
LIMS implementation
LIMS validation
IQ OQ PQ qualification
Master data management
SOP preparation
Declaration
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge. Place: Hyderabad. DateTimeline
Duty Manager in Quality Control Department
M/s. MSN Life Science Private Limited
09.2022 - Current
Sr. Executive (E4) in Corporate Quality Control Department
M/s. Aurobindo Pharma Ltd.
08.2017 - 08.2022
Sr. Executive (E3) in Quality Control Department
M/s. Aurobindo Pharma Ltd.
01.2013 - 08.2017
Executive in Quality Control Department
M/s. Inogent Laboratories Ltd.
04.2009 - 01.2013
Chemist in Quality Control Department
M/s. Gulf Oil Corporation Ltd.
10.2006 - 04.2009
Sri Venkateswara University
B.Sc.
Bharathidasan University
M.Sc. from Bio-Technology