Music
V Ananth
Quality Assurance computerized system validation
Hosur
Summary
To build a career conductive to professional and personal growth and to gain practical experience in meeting the challenges of hi-tech environment with committed & dedicated people and to work as a key player in challenging & creative environment. Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
Friendly Deputy Manager committed to creating a positive work environment through effective mentoring and coaching. Skilled in delegation and communication. Talented in leadership, staff development and training. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Overview
17
17
years of professional experience
11
11
years of post-secondary education
3
3
Languages
Work History
Deputy Manager-Quality Assurance
M/s GELTEC private limited
1 2017 - Current
- Responsible for the Implementation of GxP Applications, identifying Gaps and Continual Improvement.
- Responsible for designing, risk assessing and validating the Excel with control parameters like calculation of Cp, CpK, Control Limit and calculation Assay.
- Responsible for Computer System Validation of Configured & Customized On-Premises Enterprise Applications, Cloud Applications, Quality Control Applications, and their life cycle management.
- Responsible for GxP, Regulatory Assessment and GAMP classification and to define the validation deliverables.
- Approving User Requirement Specification (URS), Functional Specification (FS), Configuration Specification (CS), Design Specification (DS), Functional Risk Assessment (FRA), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Regression testing activities, Requirement Traceability Matrix (RTM), Project Validation Plan and Validation Summary Report.
- Responsible for Validating On-Premises Enterprise Application, Cloud Application, Web Based Application, Client Server Applications, Configurable and Customizable products PLC, HMI, DCS and SCADA through V-Model, Agile Process, and SDLC.
- Developing subject matter expertise in Computer System Validation, Quality Systems. Compliance across all the locations.
- Responsible for the Process Validation, Cleaning Validation, Equipment Qualification, Facility Qualification, Utility Validation (Purified Water, Air Handling Unit, Compressed Air, etc.,) and Temperature Mapping of Equipment and Facility for the organization.
- Responsible for the Quality Risk Management; Assessment, control, communication and review of risks to the Quality of the product across the product lifecycle.
- Responsible for identifying areas for improvement and driving for digitalization to improve the Quality System.
- Handling of QMS elements such as Change control, Deviation, OOS, OOT, CAPA and Root Cause investigate.
- Collaborated with cross-functional teams to drive business growth and achieve corporate objectives.
- Created and maintained a strong team culture that promoted high levels of collaboration, employee satisfaction, and overall performance.
Executive
M/s HIKAL Limited
02.2016 - 12.2016
- Responsible for the Process Validation, Cleaning Validation, Equipment Qualification, Facility Qualification, Utility Validation (Purified Water, Air Handling Unit, Compressed Air, etc.,) and Temperature Mapping of Equipment and Facility for the organization.
- Responsible for the Quality Risk Management; Assessment, control, communication and review of risks to the Quality of the product across the product lifecycle.
- Preparation/ review of Annual product quality review, performing process validation/ drying validation, cleaning validation which includes MACO calculation.
- Developed innovative solutions to complex problems, resulting in improved organizational performance.
- Led change management initiatives to drive cultural shifts towards continuous improvement mindsets.
- Ensured compliance with industry regulations while maintaining open lines of communication with regulatory bodies.
Junior Executive
M/s Orchid chemicals & pharmaceuticals Ltd.
11.2007 - 02.2016
- Preparing & reviewing of BPR/ BMR and BRC. Supervising and ensuring effective functioning of quality system.
- Performing validation of equipment /system related to aseptic processing as per validation master plan (SIP of equipment, HVAC system, smoke study laminar air flow, Dry Heat Sterilizer (DHS), Steam Heat Sterilizer (SHS), Process simulation study, Process validation) and reviewing of the documents. Reviewing of Alarm details generated in the plant.
- Handling of QMS elements such as Change control, Deviation, OOS, OOT, CAPA and Root Cause investigation.
- Preparing and reviewing of DQ, IQ, OQ, PQ for new facility Investigation and Route cause analysis for Deviation, OOS, OOT, Complaint, Recall, Return Goods, other quality related failure.
Education
Master of Science - Chemistry
Thiruvalluvar, Arts And Science College
Rasipuram, Namakkal, India 04.2001 - 04.2008
Bachelor of Science - Chemistry
Thiruvalluvar, Arts And Science College
Rasipuram, Namakkal, India 04.2001 - 04.2005
High School Diploma -
Government Higher Sec School
Mallur, Salem 04.2001 - 04.2001
Secondary School Education -
Government Higher Sec School
Mallur, SalemSkills
Process and procedure development
Current Location
BENGALURU
Present Employment
M/s GELTEC private limited, Attibele, Bengaluru, 01/02/17
Present Job Responsibility
- Executing/ Reviewing the HVAC validation for the manufacturing facility for the different classification.
- Qualifying the compressed air in the facility.
- Cleaning validation activity, identifying the worst-case molecule, identifying the MACO value by preparing the matrix with PDE, LD50 and TDD results.
- Carrying out the Cleaning validation with respect to allergen.
- Coordinating/ executing/ reviewing the URS, FAT documents, installation, operational and performance qualification.
- Carrying out the process validation.
- Executing/ Reviewing qualification of the equipment like blister packing machine, auto cartonater, compression machine, encapsulation machine, etc.
- Reviewing the computer system validation documents like ERP validation, PLC validation to ensure the requirement of GAMP 5 and 21 CFR part 11 compliance.
- Preparing, and executing the excel (spreadsheet) validation.
- Automate the excel with protection having various formulas like APQR, MACO calculation sheets
- Supervising and ensuring effective functioning of quality system.
- Supervising and ensuring the better control system.
- Providing support for process validation and cleaning validation.
- Qualifying the external service provider for executing the calibration, HVAC validation and compressed air qualification.
- Good knowledge in handling MS word, MS Excel and MS power point, especially in MS excel for automating excel sheets like APQR, and complex formulas like MKT.
Experience In
- Performing Validation activities like HVAC validation, process simulation, SIP, SHS, DHS validation activities and reviewing of the validation documents.
- Reviewing of Validation protocols and reports for Sterilization In place (SIP) of equipment, Steam Heat Sterilizer (SHS), Dry Heat Sterilizer (DHS), HVAC system, Laminar Air Flow system, Restricted Access Barrier System and smoke study.
- Reviewing of BMR/BPR, Cleaning Records Related to manufacturing facility.
- Preparing and reviewing of Process validation protocols and reports, Clean room validation protocols and reports.
- Performing self-inspection audit, and undergo daily rounds to API manufacturing facility and Stores.
- Reviewing of protocols and reports for Process simulation study.
- Reviewing of calibration certificates from external agency.
- Reviewing of system generated printouts from the manufacturing facility.
- Handling Quality Management System.
- Reviewing, investigating and preparing the market complaints and reviewing the Corrective and Preventive Action.
- Preparing and reviewing of SOP’s.
- Providing compliance to the audit points.
- Monitoring of cGMP and spelling with colleagues.
- Follow up the documents until get closed from the user end.
- Having good knowledge preparing reports, handling and preparing tracking reports in excel.
- Well trained to work in control environment and operating aseptic processing.
- Maintaining cGMP, and documentation.
Audit Faced
- US-FDA
- MHRA
- WHO-GMP
- TGA
- EU-GMP
- COFEPRIS-MEXICO
- INTERNAL AUDITS
Activities
- Experienced to handle MS office (word, excel and power point).
- Computer literacy programming (CLP).
Linguistic Ability
English, Tamil, Kannada
Father's Name
V. Veeraiya
Personal Information
- Date of Birth: 05/29/84
- Gender: Male
- Nationality: Indian
References
Available upon request
Disclaimer
I hereby declare that all the above information is correct and true to the best of my knowledge
Accomplishments
- Achieved quality output and simplified through effectively helping with automating the excel sheet for product quality review. Saved the 200 man days.
- Used Microsoft Excel to develop inventory tracking spreadsheets.
- Collaborated with team in the development of Artwork, product quality review.
- Developed tracking system for work completion tracking.
Interests
Playing chess
Social Media
Timeline
Executive
M/s HIKAL Limited
02.2016 - 12.2016
Junior Executive
M/s Orchid chemicals & pharmaceuticals Ltd.
11.2007 - 02.2016
Master of Science - Chemistry
Thiruvalluvar, Arts And Science College
04.2001 - 04.2008
Bachelor of Science - Chemistry
Thiruvalluvar, Arts And Science College
04.2001 - 04.2005
High School Diploma -
Government Higher Sec School
04.2001 - 04.2001
Deputy Manager-Quality Assurance
M/s GELTEC private limited
1 2017 - Current
Secondary School Education -
Government Higher Sec School
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