Derek Nexus (Assess the carcinogenic risk)
SITARAMARAJU ALLURI
GM-GMP Compliance
South Korea
Summary
Experienced pharmaceutical professional with a robust background in GMP compliance, quality assurance, and validation processes, including bio-similar products. As GMP Compliance team member at SamChunDang Pharm. Co., Ltd., ensured cGMP compliance in sterile drug product manufacturing, development and validation of processes and analytical methods, adhering to USFDA and EUGMP standards.
Expertise includes conducting comprehensive risk assessments, managing CMO facilities, and designing effective contamination control strategies. Successfully supported ANDA/CTD filings, Greenfield clean room projects, and multiple USFDA and EUGMP inspections. A collaborative team player, having worked with diverse teams globally, provides strong support to other functional units.
Overview
20
20
years of professional experience
4
4
Languages
Work History
GM- GMP Compliance
SamChunDang Pharm. Co., Ltd.
7 2019 - Current
- Responsible for ensuring cGMP compliance in the manufacturing and testing of sterile ophthalmic drug products.
- Assist in the development, validation (Process & Analytical methods), filing (ANDA/CTD), and commercial launching of generic products.
- Qualify and monitor the performance of CMO facilities for the manufacturing and testing of biosimilar products.
- Conduct gap assessments and assist in implementing new procedures and systems in line with USFDA and EUGMP requirements.
- Prepare device design history files (DHF) for ophthalmic products in multi-dose container closure systems.
- Assess and prepare risk assessments for Process, Facility, Equipment, Nitrosamine, NDSRI, Elemental Impurities, and residual solvents.
- Ensure audit compliance and prepare CAPA responses.
- Assist in handling quality events and investigations.
- Design and monitor extractable and leachable studies.
- Design and monitor contamination control strategies.
- Design and assist in aseptic process simulation studies.
- Design and assist in risk-based cleaning validation activities.
- Assist in the design, mock trials, qualification, and validation of closed restricted access barriers for bottle filling machines for sterile ophthalmic products.
- Assist in the implementation of serialization and aggregation for new products.
- Coordinate with cross-functional teams to effectively implement procedures and policies.
DGM-Projects (GMP Consultant)
Bharat Serums and Vaccines Limited
12.2017 - 05.2019
- Assisted in the implementation of cGMP compliance in the manufacturing and testing of sterile injectable drug products.
- Conducted gap assessments and aided in implementing new procedures and systems in the Production, Validation, and Engineering departments in line with USFDA and EUGMP requirements.
- Assessed and prepared risk assessments for Process, Facility, and Equipment.
- Assisted in ensuring audit compliance and prepared CAPA responses.
- Supported the handling of quality events and investigations.
- Designed and assisted in aseptic process simulation studies.
- Designed and assisted in risk-based cleaning validation activities.
Sr. Manager-Quality Assurance
Bruck Pharma Private Limited
04.2015 - 11.2017
- Assistance in cGMP compliance in manufacturing and testing of sterile oncology drug products and oral solid dosages.
- Qualification and performance monitoring of suppliers including raw materials and packaging materials.
- Assisted in cGMP compliance in the manufacturing and testing of sterile oncology drug products and oral solid dosages.
- Qualified and monitored the performance of suppliers, including raw materials and packaging materials.
- Prepared and implemented new procedures and systems in Quality Assurance, Production, Laboratory Controls, Material Management, and Utilities in line with USFDA and EUGMP requirements.
- Assisted and monitored the qualification and validation of new facilities, equipment, and utilities.
- Assessed and prepared risk assessments for Process, Facility, and Equipment.
- Assisted in handling quality events and investigations.
- Designed and monitored contamination control strategies.
- Designed and assisted in aseptic process simulation studies.
- Designed and assisted in risk-based cleaning validation activities.
- Assisted in the design, mock trials, qualification, and validation of negative isolators for dispensing, solution preparation, granulation, compression, coating, and blister packaging processes.
Manager-Validation (GMP Consultant)
SamChunDang Pharm. Co., Ltd.
02.2013 - 03.2015
- Assisted in the qualification and validations in the manufacturing and testing of sterile ophthalmic drug products.
- Conducted gap assessments and implemented new procedures and systems in the Quality Assurance, Production, Validation, and Engineering departments in line with MHRA and EUGMP requirements.
- Prepared quality risk management documentation for filling machines, sterilizers, air handling units, packaging lines, and utilities.
- Assisted in the execution of qualification activities for filling lines, packaging lines, steam sterilizers, HVAC, and utilities.
- Assisted in ensuring audit compliance and prepared CAPA responses.
- Supported the handling of quality events and investigations.
- Designed and assisted in aseptic process simulation studies.
- Assisted in risk-based process and cleaning validation activities.
Sr. Executive-Validation
Pfizer (FKA Hospira Healthcare India Pvt. Ltd.)
09.2011 - 01.2013
- Prepared protocols and reports for the commissioning and qualification of facilities, equipment, and utilities for the manufacturing of sterile injectable drug products.
- Prepared quality risk management documentation for filling lines, sterilizers, air handling units, and utilities.
- Executed qualification activities for filling lines, sterilizers, air handling units, and utilities.
Asst. Manger-Quality Assurance
Mylan (FKA SMS Pharma)
09.2008 - 09.2011
- Assisted in the implementation of cGMP compliance in the manufacturing and testing of sterile oncology drug products and drug substances.
- Assisted in the validation and filing (ANDA/CTD) of generic drug products and drug substances.
- Assisted in audit compliance and prepared CAPA responses.
- Assisted in handling quality events and investigations.
- Designed, prepared, and executed aseptic process simulation studies.
- Designed, prepared, and executed risk-based process and cleaning validation activities.
- Designed and prepared protocols and reports for the commissioning and qualification of facilities, equipment, and utilities for the manufacturing of sterile injectable drug products and drug substances.
- Executed qualification activities for sterile injectable filling lines, sterilizers, packaging lines, HVAC, and utilities.
- Assisted in the design, mock trials, qualification, and validation of negative and positive isolators.
Sr. Executive-Validation
Venus Remedies Limited
09.2006 - 09.2008
- Assisted in audit compliance and prepared CAPA responses.
- Prepared and executed aseptic process simulation studies.
- Prepared and executed risk-based process and cleaning validation activities.
- Prepared protocols and reports for the commissioning and qualification of facilities, equipment, and utilities for the manufacturing of sterile injectable drug products and drug substances.
- Executed qualification activities for sterile injectable filling lines, sterilizers, packaging lines, HVAC, and utilities.
Chemist-Quality Assurance
Gland Pharma Limited
02.2005 - 09.2006
- Performed In-Process Quality Assurance (IPQA) activities during the manufacturing and packaging operations for sterile injectable products.
- Conducted sampling of purified water, water for injection, pure steam, bulk solutions, filled containers, and finished products.
Education
Bachelor of Science - Chemistry
Pondicherry Central University
04.2004
Skills
GMP Compliance
Qualification and Validation
Quality Assurance
Quality Risk Management
Product Life Cycle Design (QbD)
Audit Compliance & CAPA Responses
ANDA/CTD
CMO/Supplier Management
Assessment of Aseptic process/Techniques
Design of Environmental Monitoring System
Accomplishments
- Assisted in the successful completion of 5 USFDA and 7 EUGMP inspections.
- Contributed to the successful execution of 4 green field clean room projects.
- Supported the registration of 4 ANDA sterile drug products (Oncology-2 & Ophthalmic-2).
- Prepared and implemented contamination control strategies and drug device history files for ophthalmic combination products.
- Assisted in the design and execution of extractable/leachable studies.
- Designed and executed risk based process and cleaning validation activities and Nitrosamine, NDSRI, Elemental & Residual Solvent risk assessments.
- Contributed to the design and validation of process isolators and closed access barrier systems.
- Assisted in the design and implementation of aseptic techniques and automatic online intervention handling systems.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
There’s no shortage of remarkable ideas, what’s missing is the will to execute them.
Seth Godin
Software
Sarah Nexus (Assess the carcinogenic risk)
Zeneth (Predict for nitrosating pathways)
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Adobe Acrobat
Interests
Hiking, cycling and movies
Talking to my friend 이성욱
Languages
English
Advanced (C1)
Hindi
Advanced (C1)
Telugu
Bilingual or Proficient (C2)
Korean
Elementary (A2)
Timeline
DGM-Projects (GMP Consultant)
Bharat Serums and Vaccines Limited
12.2017 - 05.2019
Sr. Manager-Quality Assurance
Bruck Pharma Private Limited
04.2015 - 11.2017
Manager-Validation (GMP Consultant)
SamChunDang Pharm. Co., Ltd.
02.2013 - 03.2015
Sr. Executive-Validation
Pfizer (FKA Hospira Healthcare India Pvt. Ltd.)
09.2011 - 01.2013
Asst. Manger-Quality Assurance
Mylan (FKA SMS Pharma)
09.2008 - 09.2011
Sr. Executive-Validation
Venus Remedies Limited
09.2006 - 09.2008
Chemist-Quality Assurance
Gland Pharma Limited
02.2005 - 09.2006
GM- GMP Compliance
SamChunDang Pharm. Co., Ltd.
7 2019 - Current
Bachelor of Science - Chemistry
Pondicherry Central University