JITENDRA CHETTY
Carnes Hill,NSW
Summary
Accomplished Quality Personnel with excellent Quality Assurance/Control, Laboratory, Documentation, Auditing, Managing, Organizational & Computer skills developed through in Pharmaceutical & Healthcare manufacturing sectors. Over 17 years’ experience as Analyst, Senior Analytical Chemist, Quality Control Manager, Quality Assurance Supervisor & Quality Assurance Manager possessing, detailed knowledge of Quality, Regulatory, Technical & Instrumentation Operation and principles, Knowledge of production processes and requirements. An organized and conscientious self-starter, able to strategize and prioritize effectively to accomplish multiple tasks and stay calm under pressure.
Overview
23
23
years of professional experience
Work History
QUALILTY ASSURANCE MANAGER
BLUEGUM PHARMACEUTICALS
01.2024 - Current
- Manage & Ensure Quality System Compliance with TGA, FDA, FASANZ, NSW Dairy Exports, NSW Food Authority, APVMA, ISO 9001
- Manage & Lead QA/QC Team to ensure all required tasks deadlines met
- Manage and lead all internal Audits, External Regulatory & Customer Audits
- Manage all Equipment & Process Validations
- Liaise with Suppliers and Customers and Support all internal departments on all technical and quality issues
- Assist R&D Team to develop new Formulations & Specifications as required
- Coordinate and maintain Stability Program
- Coordinate & Perform Australian Listed & Export Product Registrations Process
- Coordinate all TGA, FASANZ, Cosmetic, Pet & Export Labels for Regulatory requirements
- Apply and maintain all other relevant licenses (Food, Dairy, Organic, Halal Etc.) Manage & Coordinate all major department projects
- Continuous Management, Leading & Training of a team of 8 dedicated QC/QA staff and addressing their problems and providing regular support to them.
QUALILTY ASSURANCE SUPERVISOR
BLUEGUM PHARMACEUTICALS
12.2020 - 08.2022
- Meet the requirements to Code of GMP by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met
- Establish & maintain specifications and standards for control of raw materials, packaging and finished products
- Train all personnel on latest GMP and PIC/S guidelines
- Facilitate and improve processing in packaging, manufacturing & labelling
- Verification of batch records and authorize the release of finished product for supply
- Manage all internal & external audits
- Verify disposal of reject materials and products
- Responsible of determining conformance or non-conformance of all raw materials, packaging materials and finished products after inspection and testing
- Carry out approval and review of all validation activities, Product Quality Review, Recall Procedure, GMP Contract Agreements
- Responsible and implementation of all Change Controls, Deviations, CAPA
- Evaluation of Stability of Raw Materials & Finished Products
- Assist with New Product registration process
- Support other departments on technical and quality issues.
QUALITY CONTYROL MANAGER
BLUEGUM PHARMACEUTICALS
12.2018 - 12.2020
- Manage and coordinate the responsibilities of Quality Manager by utilizing effective scheduling and monitoring systems and managing quality systems
- Writing & managing technical reports including testing methods and SOPs, reviewing and approving lab procedures, GAM, GTM, OOS reports, Deviations, change controls, CAPA, reject notes and customer complaints
- Supervised and managed day to day activities including outsourcing testing of RM, FP and release of In-Process/Intermediate Samples, Finished Product Samples, Raw Material Samples & Stability
- Performing regular internal audits, audit follow ups, as well as external laboratory audits for all contract laboratories as well as involvement with TGA audits
- Developed and managed Quality & Regulatory Documentations to ensure adherence to meet its legal and regulatory compliance
- Prioritizing testing in accordance with production and customer demands
- Reviewing and approving analytical data and releasing products on a daily basis
- Attend daily Production & Management meetings to discuss and prioritize testing to meet customer requirements
- Initiating and facilitating laboratory investigations for any Out-of-Trend, Out-of-Specification or atypical
- Oversight of environmental monitoring, calibration, safety, housekeeping, retention management, documentation management
- Maintaining high levels of GMPs
- Standard operation procedures writing
- Performing Quality approvals
- Implementation and training of company rules and SOPs
- Train, supervise and coordinate with new staffs and review logbooks and training documents
- Performing Quality investigations for any Out-of-Trend, Out-of-Specification or Atypical
- Results analysis as per SOPs to ensure the root cause is identified and remedial action is taken
- Assist in troubleshooting, identify problems and implement corrective actions
- Team motivation and support
- Aware of responsibilities and regulations that apply to working in a TGA approved environment
- Familiarity with Occupational Health and Safety requirements
- Development and improvement of analysis procedures.
LABORATORY MANAGER
FERNGROVE PHARMACEUTICALS
07.2015 - 12.2018
- Manage and coordinate the responsibilities of analyst and laboratory personnel by utilizing effective scheduling and monitoring systems
- Supervised and managed day to day laboratory activities including allocation, testing and release of In-Process/Intermediate Samples, Finished Product Samples, Raw Material Samples & Stability
- Allocating & Prioritizing testing in accordance with production and customer demands
- Reviewing and approving analytical data and releasing products on a daily basis
- Attend daily dispatch meetings to discuss and prioritize testing to meet customer requirements
- Initiating and facilitating laboratory investigations for any Out-of-Trend, Out-of-Specification or atypical
- Oversight of calibration, safety, housekeeping, retention management, documentation management, reference standards, and reagent preparations
- Performing regular laboratory audits
- Analysis of raw materials using FTIR, UV Spectrometer following GMP’s (General Manufacturing Procedures) and GLPs
- Operating analytical instruments such as HPLC, UPLC, GC, FTIR, UV, Polarimeter, Refractometer
- Analysis of variety of finished products, nutritional vitamins and other specific actives using HPLC, ULPC, and GC
- Performing Titrations, Uniformity of content testing, Spectrophotometric assaying and Dissolution testing of tablets
- Performing analysis as per Monograph Compendia Methods and in-house methods such as GAMs (General Analytical Methods) and GTMs (General Testing Methods)
- Instruments calibrations
- Maintaining high levels of GMPs and GLPs
- Assisting with method writing and standard operation procedures writing
- Performing start-ups and approvals in absence of approval staff
- Maintaining test equipment in a clean and serviceable order and laboratory housekeeping
- Oversight of calibration, safety, housekeeping, retention management, documentation management, reference standards, and reagent preparations
- Writing technical reports including testing methods and SOPs, reviewing and approving lab procedures, GAM, GTM, OOS reports, change controls, reject notes and customer complaints
- Implementation and training of company rules and SOPs
- Train, supervise and coordinate new analysts and review logbooks and training documents
- Ensure that equipment is well maintained and serviced as required
- Assist with internal duties as required
- Performing laboratory investigations for any Out-of-Trend, Out-of-Specification or atypical
- Results analysis as per SOPs to ensure the root cause is identified and remedial action is taken
- Assist in troubleshooting, identify problems and implement corrective actions
- Enforce testing regimes
- Team motivation and support
- Aware of responsibilities and regulations that apply to working in a TGA approved laboratory
- Familiarity with Occupational Health and Safety requirements
- Development and improvement of analysis procedures.
SENIOR ANALYTICAL CHEMIST
ACTIVE PHARMACEUTICALS
03.2015 - 06.2015
- Analysis of raw materials using FTIR, UV Spectrometer & Titrations following GMP’s (General Manufacturing Procedures) and GLPs
- Operating analytical instruments such as HPLC, UPLC, FTIR, UV, Polarimeter, Refractometer
- Analysis of variety of finished products, gels, creams and other specific actives using HPLC & ULPC
- Performing analysis as per Monograph Compendia Methods and in-house methods such as GAMs (General Analytical Methods) and GTMs (General Testing Methods)
- Instruments calibrations
- Maintaining high levels of GMPs and GLPs
- Maintaining test equipment in a clean and serviceable order and laboratory housekeeping.
LABORATORY TEAM LEADER/SENIOR ANALYTICAL CHEMIST
LIPA PHARMACEUTICALS LTD
08.2011 - 02.2015
- Manage and coordinate the responsibilities of analyst and laboratory personnel by utilizing effective scheduling and monitoring systems
- Supervised and managed day to day laboratory activities including allocation, testing and release of In-Process Samples, Finished Product Samples, Raw Material Samples & Stability
- Prioritizing testing in accordance with production and customer demands
- Attend daily dispatch meetings to discuss and prioritize testing to meet customer requirements
- Navision approval-rejection and associated activities
- Enforce GLP and laboratory systems through delegation and monitoring
- Oversight of calibration, safety, housekeeping, retention management, documentation management, reference standards, and reagent preparations
- Writing technical reports including testing methods and SOPs, reviewing and approving lab procedures, GAM, GTM, OOS reports, change controls, reject notes and customer complaints
- Implementation and training of company rules and SOPs
- Train, supervise and coordinate new analysts and review logbooks and training documents
- Ensure that equipment is well maintained and serviced as required
- Assist with internal duties as required
- Performing laboratory investigations for any Out-of-Trend, Out-of-Specification or atypical
- Results analysis as per SOPs to ensure the root cause is identified and remedial action is taken
- Assist in troubleshooting, identify problems and implement corrective actions
- Enforce testing regimes
- Team motivation and support
- Aware of responsibilities and regulations that apply to working in a TGA approved laboratory
- Familiarity with Occupational Health and Safety requirements
- Coordinate the External Laboratory Samples from Quest Pharmaceuticals, i.e., Receiving, Allocation, Documentation and Release
- Development and improvement of analysis procedures
- Creating Purchase Orders for all Lab Consumables and Instruments.
ANALYTICAL CHEMIST
LIPA PHARMACEUTICALS LTD
10.2006 - 08.2011
- Analysis of raw materials using FTIR, UV Spectrometer & Karl Fisher following GMP’s (General Manufacturing Procedures) and GLPs
- Operating analytical instruments such as HPLC, UPLC, GC, ICP, FTIR, UV, Auto Titrator, Karl Fisher, Particle Size Analyzer, Polarimeter, Refractometer
- Analysis of variety of finished products, nutritional vitamins and other specific actives using HPLC, ULPC, and GC
- Performing Titrations, Metal Analysis using ICP, Uniformity of content testing, Spectrophotometric assaying and Dissolution testing of tablets
- Performing analysis as per Monograph Compendia Methods and in-house methods such as GAMs (General Analytical Methods) and GTMs (General Testing Methods)
- Instruments calibrations
- Maintaining high levels of GMPs and GLPs
- Assisting with method writing and standard operation procedures writing
- Performing start-ups and approvals in absence of approval staff
- Maintaining test equipment in a clean and serviceable order and laboratory housekeeping.
Science Teacher
01.2001 - 07.2006
- Year 10,11&12 in Schools in Fiji Islands
Education
Bachelor of Science - Chemistry & Physics
The University of the South Pacific
01.2000
Skills
- Excellent team management skills
- Strong organization skills, ability to manage multiple tasks, priorities and efficient
- Ability to acquire skills quickly and communicate complex ideas in clear language
- Excellent attention to detail skills
- Proficient in MS Office, Navision, Pronto, 3WS, Empower & Lab Solutions Software
- Ability to meet deadlines and work under conflicting time pressures within a team
- Self-manageable and highly motivated
- Proven ability to communicate clearly, concisely, and effectively in writing scientific documentations and face to face with colleagues, senior managers and external organizations
- Strong commitment to Good Manufacturing Practice and Laboratory Safety
- Technical report writing
- Detail knowledge of Deviations, Change Controls, Documentation Control, Risk Assessments, CAPA, Product Recalls, Customer Complaints
- Well versed with UPLC & HPLC & ICP instruments & software
- Separation and purification techniques
- High-Performance Liquid Chromatography
- Quantitation for quantitative analysis
- Materials planning
- Trained in lab safety
- Tuning and calibration
References
Available on request
Timeline
QUALILTY ASSURANCE MANAGER
BLUEGUM PHARMACEUTICALS
01.2024 - Current
QUALILTY ASSURANCE SUPERVISOR
BLUEGUM PHARMACEUTICALS
12.2020 - 08.2022
QUALITY CONTYROL MANAGER
BLUEGUM PHARMACEUTICALS
12.2018 - 12.2020
LABORATORY MANAGER
FERNGROVE PHARMACEUTICALS
07.2015 - 12.2018
SENIOR ANALYTICAL CHEMIST
ACTIVE PHARMACEUTICALS
03.2015 - 06.2015
LABORATORY TEAM LEADER/SENIOR ANALYTICAL CHEMIST
LIPA PHARMACEUTICALS LTD
08.2011 - 02.2015
ANALYTICAL CHEMIST
LIPA PHARMACEUTICALS LTD
10.2006 - 08.2011
Science Teacher
01.2001 - 07.2006
Bachelor of Science - Chemistry & Physics
The University of the South Pacific
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