Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sudhakaru B

Ranga Reddy District

Summary

Experienced manager with a proven track record of leading teams to success through strong leadership, strategic planning, and exceptional organizational abilities. Skilled in empowering employees to efficiently manage daily operations and exceed customer expectations. Demonstrated ability to drive operational efficiency and achieve business objectives in a fast-paced environment.

Overview

22
22
years of professional experience

Work History

Manager- QC

NATCO Pharma Limited
04.2022 - Current
  • Company Overview: Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.
  • Leading team of 16 members.
  • To plan & organize sampling and Analysis of water, Raw material, Packing Materials, Environmental Monitoring, in process, stability and finished products analysis and maintain the records as per GLP,cGMP and to fulfil the requirement of 21 CFR part 11. Sample approval in respective LIMS software for the microbiology test.
  • To solve any day to day problem, pertaining to testing of any material faced by Analyst/Reviewer.
  • Preparation & Review of SOP, Method validation protocol, qualification protocol, STP & GTP Test data sheet and study protocol and ensure the effective implementation of the same.
  • Handling of CCF, Lab incident, OOS, OOL and Deviation.
  • Handling of Instrument procurement and Instrument Qualification document –IQ, OQ, PQ. To ensure calibration, validation & AMC for certain instruments/equipment’s used in the department and Ensure all instruments/equipment’s are in calibrated condition. Annual master plan for calibration/ validation, AMC of equipment/instrument.
  • Monitoring of the activities in laboratory and ensuring the microbiologist are following the activities as per the respective SOP. To compliance as per requirement of data integrity.
  • To ensure adequate stock, consumable Spares, consumable items and glassware’s.
  • On job training to new employee and handling and maintaining the trailing records in Microbiology department.
  • Validation and qualification like HVAC qualification, Water system, Disinfectant validation, Analyst qualification, Autoclave, Personal qualification.
  • Ensured the GLP practices are strictly followed with thorough knowledge of 21 CFR requirements. To approve all the test reports and documents to ensure complies of SOP & GLP.
  • Ensuring the safe disposal of biological waste as per the requirement.
  • To evaluate, discuss and submit performance appraisal of subordinate staff to AGM.
  • Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.
  • Successfully faced Regulatory Audit (Ministry of Industry and Trade of Russia) and customer Audit at Natco Pharma Ltd.
  • Successfully faced USFDA audit, Indian FDA audit and ISO audit as section head for Microbiology section at Natco Pharma Ltd.
  • Assisted to various sites of Natco Pharma Ltd for internal review as well as audit preparation.
  • In Natco pharma faced USFDA, MHRA & TGA. Prepared all the microbiology compliance protocol and SOPs.
  • Work with QC team (Environment monitoring program, Review of training program and records, Review of sample management transfer process from production area to QC) in ESPI Industries and Chemicals Pvt. Ltd.
  • Participated in Establishment of New QC Microbiology laboratory at Natco pharmaceutical Ltd; Vizag.
  • Participated in Corporate Microbiology SOP preparation.

Deputy Manager- QC

NATCO Pharma Limited
04.2018 - Current
  • Company Overview: Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.
  • Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.

Assistant Manager –QC

NATCO Pharma Limited
04.2014 - 03.2018
  • Company Overview: Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.
  • Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.

Executive-QC

NATCO Pharma Limited
11.2009 - 03.2014
  • Company Overview: Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.
  • Currently working in NATCO Pharma Limited, (USFDA, ISO, ANAB etc.) manufacturing Oral Solid Dosages such as Tablets, Capsules, Inhalers and pellets, oral suspensions etc. in Formulation Unit of Kothur, Rangareddy District, Telangana.

Executive (Microbiologist- QC)

BIOMAX Life Sciences Limited
09.2006 - 10.2009
  • Company Overview: Secondly worked in BIOMAX Life Sciences Limited, (ISO: 9001-2000 certified) Biotech industry, manufacturing Biopharmaceutical, Nutraceutical’s and Herbal products in the location of S.P.Biotech Park, Ranga reddy District-76. Telangana.
  • Secondly worked in BIOMAX Life Sciences Limited, (ISO: 9001-2000 certified) Biotech industry, manufacturing Biopharmaceutical, Nutraceutical’s and Herbal products in the location of S.P.Biotech Park, Ranga reddy District-76. Telangana.

Jr.Executive -QC

ESPI Industries and Chemicals Private Limited
08.2003 - 08.2006
  • Company Overview: Initially worked in ESPI Industries and Chemicals Private Limited, (manufacturing Antacids, vitamin-mineralized syrups, cough –fever, dry powders and tablets etc.), Formulation Unit, Hyderabad-39, Telangana.
  • Initially worked in ESPI Industries and Chemicals Private Limited, (manufacturing Antacids, vitamin-mineralized syrups, cough –fever, dry powders and tablets etc.), Formulation Unit, Hyderabad-39, Telangana.
  • Where we worked for esteemed Organizations like – Ranbaxy Laboratories Ltd., Dr. Reddy’s Laboratories Ltd., Wyeth Ltd., Polaris (Aurobindo Citadel Pharmaceuticals), Nicholas Piramal India Ltd & Albert David Ltd., East India Pharmaceuticals and Works Limited.

Education

Master of Science -

Z.P.H School, Year:1996 Percentage:79.7
Oravakal, Kurnool, Andhra Pradesh.
01-2003

Skills

  • Work prioritization
  • Performance evaluations
  • Time management
  • Complex Problem-solving
  • Risk management
  • Cross-functional team management
  • Regulatory compliance
  • Resource allocation
  • Shift scheduling
  • Decision-making
  • Trend analysis

Timeline

Manager- QC

NATCO Pharma Limited
04.2022 - Current

Deputy Manager- QC

NATCO Pharma Limited
04.2018 - Current

Assistant Manager –QC

NATCO Pharma Limited
04.2014 - 03.2018

Executive-QC

NATCO Pharma Limited
11.2009 - 03.2014

Executive (Microbiologist- QC)

BIOMAX Life Sciences Limited
09.2006 - 10.2009

Jr.Executive -QC

ESPI Industries and Chemicals Private Limited
08.2003 - 08.2006

Master of Science -

Z.P.H School, Year:1996 Percentage:79.7

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Sudhakaru B