Experience

New Beta Innovation Canada Limited

• Canada
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Manager

  • Jan 2022 - Present

  • Manage validation team in all validation/qualification related activities• Act as a SME for commissioning, qualification and validation of equipment, utilities, facilities, computerized system validation, transport validation and analytical and microbial method validation• Ensure site qualification and validation program is compliant with cGMP and regulatory requirements• Lead commissioning, qualification and validation team to successful completion of relevant activities• Lead the inspection preparation and see through the inspections from the validation perspective• Review and approve commissioning, qualification and validation documentations of equipment, utilities, facility with the focus on compliance with the regulatory requirements and company policies (e.g. URS, DQ, FDS, FAT/SAT documents, commissioning documents, IOQ, PQ, validation plan, risk assessment, validation summery report, SOPs, computerized system validation documents, analytical and microbial method validation documents • Work closely with QA department to review and approve deviation, non-conformance, change control, CAPA (events) reports, records, investigations, risk assessment and SOPs. • Own and maintain the validation master plan • Lead the establishment and maintenance of the validation/qualification periodic review program, including setting up the periodic review plan, performing periodic reviews and supporting validation works from QA perspective• Support Engineering & Maintenance to set up a preventive maintenance and calibration program to ensure compliance with GMP requirements, and perform oversight on calibration and maintenance activities• Support the setup other validation programs and activities including process and cleaning• Develop annual operating budget for department and manage expenditures• Lead, coach and support employees with their career planning and development Show less

• Assistant Manager - Validation

  • Jan 2020 - Jan 2022

  SME for commissioning, qualification and validation of equipment, utilities, facilities, computerized system validation, transport validation, analytical method validation and microbial method validation.Leading C&Q and Validation team to successful completion of activities. Leading regulatory inspections from validation perspective.Review and approve commissioning, qualification and validation documents for facility, utilities, equipment - URS, DQ, FDS, FAT/SAT, commissioning, IOQ, PQ, validation plan, risk assessment, validation summary report, SOPs, computerized system validation and method validation. Maintaining validation master plan and validation periodic review program. Reviewing deviation, non-conformance, change control, CAPA from validation perspective. Supporting Engineering and Maintenance to setup a preventive maintenance and calibration program to ensure compliance with GMP requirements and overseeing calibration and maintenance activities. Supporting to setup cleaning and process validation program. Supporting to setup and perform internal audit program. Leading validation team, developing and coaching validation team members. Show less

• Sr. Specialist, QA

  • Jul 2018 - Jan 2020

  • Performing review and approval of commissioning, qualification and validation of equipment, utilities, facility and processes with the focus on cGMP compliance • Maintaining the equipment validation program and reviewing all validation documents in the validation lifecycle to ensure compliance• Reviewing and approving deviation, non-conformance, change control, CAPA • Developed and maintaining validation periodic review program• Supporting Engineering and Maintenance for the PM and Calibration program to ensure GMP compliance• Supporting Quality Control for the review, approval and QA oversight of QC activities- method validation, equipment qualification, routine analysis of raw material and finished product • Leading the inspection from validation perspective• Developed internal audit program and performing QC and Engineering audit• Supporting validation programs and activities including – process, method, cleaning, transportation. Show less



CRL Synergy- Cosmaceutical Research Inc.

• Validation Leader

  • Oct 2014 - Apr 2018

  • Worked as team leader for the development of analytical methods (USP) , formulation, and wet chemistry techniques, process and cleaning. • Product development formulation and process – Oral Wound Cleanser (NPN- Oral), Pain Relief Creams (NPN and DIN, Topical), Nasal Decongestant Spray (NPN and DIN- Nasal) • Implemented advance analytical and wet chemistry techniques- Viscometer-DV2T RheocalcT , Density Meter- Anton Paar, Wet chemistry techniques, HPLC-DAD, GC-FID, UV-Vis, FTIR etc. • Overseen stability program, temperature and humidity mapping and QC investigations, contract lb relations • Developed raw materials, packaging material and finished product specifications for the new products • Developed SOPS, project plan, master validation plan (process and cleaning), user requirement specifications, equipment commissioning plan, method validation • Developed cross contamination residual trace procedures (microbiological and chemical) • Demonstrated versatile skills as a leader during nasal decongestion solutions project formulation development, analytical method development, commissioning and qualification stages. • Actively participated to improve procedures for packaging and validation of assembly lines • Supervised analytical instrument qualification program • Developed and performed equipment qualification, process validation, cleaning validation and packaging validation for the overall site • Demonstrated excellent team leadership skills, communication skills and time management skills on daily activities through several stages of manufacturing • Actively participated in the normal and accelerated stability program of new products. Directed the project from research and development stage to operations and marketing stage efficiently • Resolved technical challenges and acted as key technical individual for the customer complaints • Managed SR&ED activities and successfully faced SR&ED CRA audit with full claimed amount credit Show less



IKO Roofing

• Building Materials

• Lab Consultant

  • Feb 2014 - Jul 2014

  • Consulted operations for premium quality measures • Conducted daily sample analysis of Asphalt, filler and granules as per ASTM methods • Conducted Organic Extractions, Flash point, density, Viscosity, Particle size analysis, Softening points, Penetration reading, Tear testing and Tensile Strength measurements • Reported criticality readings to the production management for the proper adjustment • Maintained calibration measures and commercial standard for FM and CSA license • Consulted operations for premium quality measures • Conducted daily sample analysis of Asphalt, filler and granules as per ASTM methods • Conducted Organic Extractions, Flash point, density, Viscosity, Particle size analysis, Softening points, Penetration reading, Tear testing and Tensile Strength measurements • Reported criticality readings to the production management for the proper adjustment • Maintained calibration measures and commercial standard for FM and CSA license



GlaxoSmithKline

• United States
• Investment Management

• Validation Specialist

  • Oct 2012 - Jan 2014

  Cleaning Validation, Process Validation, Equipment validation, Implementing Product formulation into quality critical matrix. Swab sampling, Rinse water sampling for Hypochlorite and Hydrogen Peroxide, Chemistry and Microbiology Swabbing, Coordinating with Chemistry and Microbiology Department for Test Results and Possible impact on Quality of Product as well as System. Deviation investigation on the failure of test results (assessment of quality impact for deviations). Design of Experiment, Equipment qualification, Protocol generation; Writing summary reports; Calibration of instruments, Clear understanding of cleaning validation, Knowledge of CIP and COP cycle development, Field sampling to perform TOC, Conductivity, Endotoxin, and Microbial testing, Generation of Validation Protocols, Reports, SOPs and Batch Records, Defining Boundaries of Equipment. Show less



Sanofi Pasteur

• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Pharmaceutical Consultant

  • Apr 2011 - Sep 2012

  Vaccines Manufacturing and Filling environment Working as a Manufacturing Technician (Biofinisher) Lead Operator-Protein Formulation and Filling FDA, OSHA,ISO, cGMP Compliance , Aseptic techniques Following Strict Good Documentation Practices (GDP), standard work instruction (SWI), standard operating procedures SOPs – guidelines, Clean Room Environment  Aseptic Gowning- class A (100) qualified  Following Laboratory Log books, BFR (Bach Filling Record)  Working as an lead operator of Clean In Process (CIP), Sterilization In Process (SIP), Disinfection, Hydrophobic Filter testing, Autoclave, HMI operating system, Depyrogenation process, Phase I, II set up and Aseptic Filling process Sample analysis (Aluminum colloidal optical transmition-Adacel Vaccine) by spectrophotometer Environment Monitoring, Class A (0) Class B (100) environment sampling- Master Data Base- entering environment samples Volume analysis- Critical Task Handling, Manufacturing Troubleshooting Mechanical aptitude-Automation Show less



University of Scranton

• United States
• Higher Education
• 700 & Above Employee

• Graduate Assistant- OSHA

  • Feb 2009 - May 2010

  Assistant Chemical Hygiene Officer- OSHA Assistant Chemical Hygiene Officer- OSHA