SITARAMARAJU ALLURI
GM-GMP Compliance
HWASEONG-SI,GYEONGGI-DO
Summary
Experienced pharmaceutical professional with a robust background in GMP compliance, quality assurance, and validation processes, including bio-similar products. As GM of GMP Compliance at SamChunDang Pharm. Co., Ltd., ensured cGMP compliance in sterile product manufacturing, led the development and validation of processes and analytical methods, and adhered 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, led greenfield clean room projects, and facilitated multiple USFDA and EUGMP inspections. A collaborative team player, having worked with diverse teams globally, providing strong support to other functional units.
Overview
20
20
years of professional experience
Work History
GM- GMP Compliance
SamChunDang Pharm. Co., Ltd.
Hwaseong, South Korea
7 2019 - Current
- Responsible for cGMP compliance in manufacturing and testing of sterile ophthalmic drug products.
- Assistance in development, validation (Process & Analytical methods), filing (ANDA/CTD) and commercial launching of generic products.
- Qualification and performance monitoring of CMO facilities for manufacturing and testing of bio-similar products.
- Gap assessment and assistance in implementation of new procedures and systems inline with USFDA and EUGMP requirements.
- Preparation of device design history files (DHF) for ophthalmic products in multi-dose container closure system.
- Assessment and preparation of Process, Facility, Equipment, Nitrosamine, NDSRI, Elemental Impurities and residual solvents risk assessments.
- Responsible for audit compliance and CAPA responses.
- Assistance in handling of quality events and investigations.
- Responsible for design and monitoring of extractable and leachable studies.
- Design and monitoring of contamination control strategies.
- Design and assistance in aseptic process simulation studies.
- Design and assistance in risk based cleaning validation activities.
- Assistance in design, mock trials, qualification and validation of closed restricted access barriers for bottle filling machine for sterile ophthalmic products.
- Assistance in implementation of serialization and aggregation for new products.
- Boosted customer satisfaction by implementing effective communication strategies and addressing concerns promptly.
- Coordination with cross-functional teams for effective implementation of procedures and policies.
DGM-Projects (GMP Consultant)
Bharat Serums and Vaccines Limited
Mumbai, India
12.2017 - 05.2019
- Assistance in implementation of cGMP compliance in manufacturing and testing of sterile injectable drug products.
- Gap assessments and assistance in implementation of new procedures and systems in Production, Validation and Engineering departments inline with USFDA and EUGMP requirements.
- Assessment and preparation of Process, Facility, Equipment risk assessments.
- Assistance in audit compliance and CAPA responses.
- Assistance in handling of quality events and investigations.
- Design and assistance in aseptic process simulation studies.
- Design and assistance in risk based cleaning validation activities.
Sr. Manager-Quality Assurance
Bruck Pharma Private Limited
Daman, India
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.
- Preparation and implementation of new procedures and systems in Quality Assurance, Production, Laboratory Controls, Material Management and Utilities inline with USFDA and EUGMP requirements.
- Assistance and monitoring of Qualification and validation of new facilities, equipment and utilities.
- Assessment and preparation of Process, Facility, Equipment risk assessments.
- Assistance in handling of quality events and investigations.
- Design and monitoring of contamination control strategies.
- Design and assistance in aseptic process simulation studies.
- Design and assistance in risk based cleaning validation activities.
- Assistance in 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.
Hwaseong, South Korea
02.2013 - 03.2015
- Assistance in Qualification and validations in manufacturing and testing of sterile ophthalmic drug products.
- Gap assessments and assistance in implementation of new procedures and systems in Quality Assurance, Production, Validation and Engineering departments inline with MHRA and EUGMP requirements.
- Preparation of quality risk management documentation for filling machine, sterilizers, air handling units, packaging line and utilities.
- Assistance in execution of qualification activities for sterile bottle Bottle filling machine, Packaging Line (Bottle labeling machine, Auto Carton packing machine, serialization and aggregation) Steam Sterilizers, Air Handling Units/Clean equipments and Utilities (Purified Water, Water For Injection, Pure Steam, Nitrogen and Compressed air).
- Assistance in audit compliance and CAPA responses.
- Assistance in handling of quality events and investigations.
- Design and assistance in aseptic process simulation studies.
- Design and assistance in risk based cleaning validation activities.
Sr. Executive-Validation
Pfizer (FKA Hospira Healthcare India Pvt. Ltd.)
Visakhapatnam, India
09.2011 - 01.2013
- Design and preparation of protocols/reports commissioning and qualification of facilities, equipment and utilities for manufacturing of sterile injectable drug products.
- Preparation of quality risk management documentation for sterile injectable filling line, sterilizers, air handling units and utilities.
- Execution of qualification activities for sterile injectable Filling Line (Vial/Ampoule Washing Machine, Filling Machine, Capping Machine, Sterilizers (Tunnel & Steam), Air Handling Units and Utilities (Purified Water, Water For Injection, Pure Steam, Nitrogen and Compressed air)).
Asst. Manger-Quality Assurance
Mylan (FKA SMS Pharma)
Visakhapatnam, India
09.2008 - 09.2011
- Assistance in implementation of cGMP compliance in manufacturing and testing of sterile oncology drug products and drug substances.
- Assistance in validation and filing (ANDA/CTD) of generic drug products and drug substances.
- Assistance in implementation of new procedures and systems inline with USFDA and EUGMP requirements.
- Responsible for audit compliance and CAPA responses.
- Assistance in handling of quality events and investigations.
- Design, preparation and execution of aseptic process simulation studies.
- Design, preparation and execution of risk based process and cleaning validation activities.
- Design and preparation of protocols/reports commissioning and qualification of facilities, equipment and utilities for manufacturing of sterile injectable drug products and drug substance.
- Execution of qualification activities for sterile injectable Filling Line (Vial Washing Machine, Filling Machine, Lyophilizer, Capping Machine) Sterilizers (Tunnel & Steam), Vial Labeling machine, Air Handling Units/Clean equipment and Utilities (Purified Water, Water For Injection, Pure Steam, Nitrogen and Compressed air).
- Assistance in design, mock trials, qualification and validation of negative isolators (dispensing, charging, collection, milling, blending, packaging process of drug substance) and positive isolators for manufacturing, filtration, filling, lyophilization, capping and external washing processes of drug products).
Sr. Executive-Validation
Venus Remedies Limited
Baddi, India
09.2006 - 09.2008
- Assistance in audit compliance and CAPA responses.
- Preparation and execution of aseptic process simulation studies.
- Preparation and execution of risk based process and cleaning validation activities.
- Preparation of protocols/reports commissioning and qualification of facilities, equipment and utilities for manufacturing of sterile injectable drug products and drug substance.
- Execution of qualification activities for sterile injectable Filling Line (Vial/Ampoule Washing Machine, Filling Machine, Lyophilizer, Capping Machine) Sterilizers (Tunnel & Steam), Vial Labeling machine, Air Handling Units/Clean equipment and Utilities (Purified Water, Water For Injection, Pure Steam, Nitrogen and Compressed air).
Chemist-Quality Assurance
Gland Pharma Limitd
Hyderabad, India
02.2005 - 09.2006
- Responsible for in-process quality assurance (IPQA) activities in manufacturing and packaging operations for sterile injectable drug products
- Sampling of purified water, water for injection, pure steam, bulk solution,filled containers and finished products
- Monitoring of dispensing, manufacturing, filling, capping, visual inspection and packaging activities
- Spot checks during filling, capping, visual inspection and packaging activities.
Education
Bachelor of Science - Chemistry
Pondicherry Central University
04.2004
Accomplishments
- Assistance in successful completion of 5 USFDA and 7 EUGMP inspections.
- Assistance in successful completion of 4 green field clean room projects.
- Support in successful registration of 4 ANDA sterile drug products (Oncology-2 & Ophthalmic-2).
- Preparation and implementation of contamination of control strategies and drug device history files (ophthalmic products).
- Assistance in design and execution of extractable/leachable studies.
- Design and execution of risk based process and cleaning validation activities and Nitrosamine, NDSRI, Elemental & Residual Solvent risk assessments.
- Assistance in design and validation of isolators and closed access barrier systems.
- Assistance in design and implementation of aseptic techniques and automatic online intervention handling systems.
Work Preference
Work Type
Full TimePart TimeContract WorkWork Location
On-SiteRemoteHybridImportant To Me
Career advancementCompany CultureFlexible work hoursTeam Building / Company RetreatsSkills
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
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 Limitd
02.2005 - 09.2006
GM- GMP Compliance
SamChunDang Pharm. Co., Ltd.
7 2019 - Current
Bachelor of Science - Chemistry
Pondicherry Central University
Similar Profiles
SITARAMARAJU ALLURISITARAMARAJU ALLURI
GM- GMP Compliance at SamChunDang Pharm. Co., Ltd.GM- GMP Compliance at SamChunDang Pharm. Co., Ltd.
ANJU A FANJU A F
Accountant at Pharm O SalesAccountant at Pharm O Sales
Jordan StapelbergJordan Stapelberg
Pharmacy Technician at Alpha Pharm Bracken CityPharmacy Technician at Alpha Pharm Bracken City
Cera HongCera Hong
Translator at VolunteerTranslator at Volunteer
SAJID AFZALSAJID AFZAL
Worker at Workers' Compensation Board - AlbertaWorker at Workers' Compensation Board - Alberta