Radiopharmaceutical Consultant Specific To: QA, QC, GMP, GMP internal Audits, Health Canada GMP Inspections and Expert

Expertise

• Radiopharmaceutical industry experience ranging from, Quality Assurance, (QA) Quality Control (QC), Good Manufacturing Practice (GMP), GMP internal audits, Health Canada GMP inspections, deviation handling and implementation of Corrective and Preventative Action (CAPA), change controls stability program, and validation.
• Oversee fast-paced radiopharmacy production environment.
• Quality Assurance Manager, applying over15 years of global experience in the radiopharmaceuticals industry.
• Demonstrated extensive and consistent focus on customer satisfaction, continuous improvement initiatives, and quality compliance for internal and external audits.
• Built a strong standing for effective site management and readiness, through the development of rigorous and detail-oriented quality assurance programs.
• Excellent problem solver with solid interpersonal skills to handle conflicts in a fast-paced radiopharmaceuticals production environment.

Leadership:

• Problem Solving
• Site Operations
• Validation Stability and Testing.

Quality Assurance (QA)

• Site QA Program Implementation/Management
• GMP (Good Manufacturing Practice) Compliance
• Project management
• Internal GMP Audits and regulatory audits
• Continuous Process Improvement
• Deviations Handling & Change Controls
• Validation
• Annual Product Quality Reviews
• Annual Trending Reports
• GMP Audits
• Document Control
• Data Analysis
• Technical Writing
• Quality Control Testing
• Deviations and CAPAs
• Change Control

Experience

Independent Consultant, 2018 - Present

Isologic Innovative RadioPharmaceuticals, Burlington, ON, Canada, 2014 - 2018 

Site Quality Assurance Coordinator

• Managed the site quality assurance program in compliance with site policies, procedures, and government regulations.
• Managed all site deviations, CAPAs, change controls, product complaints and adverse events, product recall, stability program, annual trending reports, internal and external regulatory audits, document control process, validation activities, equipment calibration, wrote Standard Operating Procedures, (SOP) trained site personnel on GMP and site procedures, batch record review and product release in real time as well as managed inspection and release of all critical materials.
• Real time Batch Release of dispensed radiopharmaceuticals: Performed Real-time QA review and release for over 1200 dispensed radiopharmaceuticals. This involved thorough review of Master Formula against compounding procedures and QC procedures daily in a fast-paced Production environment.
• Microbiological Environmental Monitoring Program: Managed the site enhanced Microbiological Environmental Program (EM) through extensive Environmental sampling. Yearly 960 samples were taken and incubated inhouse, recorded colony counts, logged deviations, implemented effective CAPAs (Corrective and Preventative Actions), wrote Impact Assessments and detailed investigation reports and closed deviations on time.
• Implementation of new Products: Implemented new products such as Mebrofenin (Special Access Programme) Cardiolite (LMI), Disofe (ERC), Mertiatide and Octreoscan, through a change control mechanism. Created new procedures, planned and executed stability studies, trained personnel in compounding and QC prior to new product offering to customers.
• Stability Program: Successfully executed enhanced stability studies on existing products such as DTPA, MDP, Sestamibi, Pertechnetate, MAA and Sulfur Colloid and established extended expiry times. These projects were implemented through change control, validations, and revision of procedures.
• Extended shelf life proved to be advantageous to distant ISOlogic customers.
• Air Particulate Sampling-Area Classification: Efficiently managed the site Air Particulate Sampling and certifications of nine critical equipment in compliance to site QA procedures and regulatory compliance.
• Deviations and Corrective and Preventative Actions (CAPAs): Efficiently handled nearly 100 site deviations and implemented effective Corrective and Preventative Actions (CAPA).
• QC Out of Specifications (OOS) results.
• Microbiological Environmental excursions.
• Equipment failure, out of specifications, malfunction.
• Stability testing OOS.
• Non-adherence to Standard Operating Procedures/Master Formula.
• Facility issues relating to water seepage, power outage.
• Identified immediate corrections, CAPAs, wrote detailed investigation reports, impact assessments, justifications and closed all deviations in accordance with site Deviation SOP.
• Change Controls: Efficiently handled nearly 35 change controls from initiation to closure relating to new equipment, new product, extension of product expiry, new QC methods, processes, and company transition.
• Enabled smooth transition of site QA program during company merger and transition.
• Product Complaints and Adverse Events
• Efficiently and independently managed all the Product Complaints and Adverse Events, wrote professional acknowledgement customer letters, performed detailed and accurate investigations and closed all complaints in a timely manner.
• GMP Internal Audits and Regulatory Audits: Demonstrated leadership skills by executing multiple core QA activities in preparation for Health Canada GMP Inspection and GMP Internal Audits.
• Training of Production personnel in Quality Control.
• Conducted Practical and theoretical QC training to 6 site personnel, completed QC Qualification Protocol, collated data and wrote Final Qualification Summary for new QC trainees.

Cardinal Health Canada, Burlington, ON, Canada, 2011 - 2014

Quality Assurance Lead

• Created and executed new validation protocol procedures for the site.
• Interfaced with customers on issues pertaining to product quality and adverse events.
• Prepared site for internal GMP audits and external regulatory audits (Health Canada).
• Coordinated the annual stability, environmental microbial sampling, and aseptic validation programs.
• Documented deviation reports and change controls for new products, QA methods, and processes.
• Executed Quality Control testing and inspection and release activities: Introduction of Varian ITLC-SG as an alternative to Pall ITLC-SG.
• Chromatography paper (ITLC-SG) supply interruption from Pall Corporation necessitated the immediate need to research and implement a new vendor.
• Drove initiative and led the project, wrote QC material Qualification protocol, executed protocol, assessed new vendor and successfully implemented Varian ITLC-SG through a change control mechanism.
• Mitigated supply issues with Pall Corporation and streamlined QC workflow, with no interruption to QC testing activities.
• Qualification of new equipment: Created and executed the Headblock Qualification Protocol critical to Sestamibi preparation.
• Prepared Validation Summary reports, hat ensured 100% GMP compliance to site policies and procedures and Health Canada regulations.
• New Product Launch-Sestamibi: Led the implementation of Sestamibi(Covidien) through a change control mechanism. Created new Quality control testing Procedure, forms and validation protocols. Qualified Headblock equipment.
• Successfully executed stability studies and established product expiry.
• Temperature mapping studies during transportation: Led the project to address the Health Canada GMP observation.
• Strategically planned real-time temperature mapping studies during transport under extreme weather (summer and winter) conditions. The 30-day continuous mapping exercise was conducted during delivery runs to 5 long distant customers. The study concluded successfully, and data provided higher level of confidence in the quality of the distributed radiopharmaceuticals.
• New QC method: Successfully implemented the new QC method for Macro Aggregate albumin (MAA) to align with the manufacturer’s Product Monograph.
• Wrote MAA QC qualification protocol and executed protocol successfully. Drafted new QC procedure and implemented test method. This ensured 100% GMP compliance.
• Document Control: Improved efficiency by leading the Document Control Process for over 100 documents.
• Established a structured approach in SOP issuance and distribution. Wrote work instructions, managed process workflow and updated policy manuals. This led to consistency in GMP practice and creation of new policies and procedures for Canadian Radiopharmacies.
• Deviations and Corrective Actions (CAPA): Efficiently handled nearly 50 site Deviations relating to;
• QC Out of Specifications (OOS) results
• Microbiological Environmental excursions
• Equipment failure, out of specifications, malfunction
• Stability testing OOS
• Procedures not being followed
• Power Outage
• Identified immediate corrections, CAPAs, wrote detailed investigation reports, impact assessments, justifications and closed all deviations in accordance with site deviation SOP.
• Change Controls: Efficiently handled nearly 20 change controls from initiation to closure relating to new vendor, new product, extension of product expiry times, new QC methods and company transition.

GE Healthcare Canada, Burlington, ON, Canada, 2005 - 2011

Quality Assurance Analyst                                                

• Created new Standard Operating Procedures, change controls deviation reports, and annual trending reports.
• Nominated to GE-Validation Expert Group due to extensive involvement in executing validation procedures.
• Assisted in Product complaints and Adverse events.
• Coordinated Document Control processes for all site Policies and Procedures.
• Implementation of new QC method: Introduced a new QC method for testing a high-volume product i.e., Myoview using ITLC-SA chromatography test method.
• Designed and executed qualification protocol through a change control mechanism.
• Created new procedure and successfully launched the method as per Health Canada regulations and approval. This method aligns with the test method outlined in the manufacturer’s Product Monograph as opposed to the previous QC test method. This brought 100% site QA compliance.
• Implementation of a new Vendor: Solved service issues with radiation equipment service provider through identifying new vendor and effectively delivering change through change control processes.
• Utilized novel tracking mechanisms that led to more transparency and improved customer service.
• Introduction of new procedures: Proactively contributed in the building of quality plan by introducing key new procedures to ensure operational compliance to GMPs.
• Devised flow analysis, addressed compliance gap, launched discussions with various key stakeholders to define and streamline procedures to identify their needs.
• Translated stakeholder needs into effective strategy and created procedures and support tools. key SOPs (Standard Operating Procedures):
• Inspection and release of components, chemicals, vials and misc. products.
• Inspection and release of incoming drugs and medical devices.
• Annual Product Quality Review: ITLC-QC testing – Myoview SA method: Qualification of QC chemicals from other vendors.
• Temporary supply shortages minimized, and continued assurance of material availability.
• Tackled business objective to secure alternate source of supply of critical QC chemicals.
• Using clear thinking, QC expertise and leadership skills researched, identified, conducted QC tests and utilized new statistical tools to qualify materials from various suppliers through Change control.
• QC materials from other vendors were approved and included in approved vendor list.
• Implementation of new disinfectants in sanitation program.
• Evolved sanitation program through researching and recommending an alternate disinfectant (Accel TB wipes) for use in Canadian radiopharmacies.
• Completed thorough analysis and developed disinfectant matrix profile. Guided discussion with QA group and utilized external study experts and qualified disinfectant through Change control. New product has improved ease of use, cost reduction of over 40% and environmentally friendly. Improved sanitation program has been successful.
• Validation Projects: Nominated to GE Validation Expert Group.
• Validation Protocol design and execution of 4 refrigerator units and incubator, prepared Validation Summary reports.
• Validation protocol design and execution of Myoview ITLC-SA and Varian ITLC-SG method and prepared Validation Summary Reports.
• Deviations and Corrective Actions (CAPA).
• Efficiently handled nearly 25 site Deviations and implemented effective CAPAs.
• Change Controls: Efficiently handled nearly 10 change controls from initiation to closure relating to new vendor, new product and new QC methods.

National Physical Laboratory, (NPL), Teddington, United Kingdom, 2002 - 2004

Assistant Research Scientist                                            

• Calibration of radionuclide solutions for UK hospitals. This involved differential weighing, radioactive source preparation, ionization chamber measurements and preparation of UKAS (United Kingdom Accreditation Service) certificates.
• Determination in variation in wall thickness of 150 British standard ampoules using 241Am dipstick measurements with secondary ionization chambers.
• Conducted monthly radioactive inventory of more than 3000 radioactive sources for the ionizing radiation group.
• Managed UKAS Audit independently and received UKAS auditor recognition.

Board of Radiation & Isotope Technology, (BARC), Mumbai, India, 1987 - 1991

• Scientific Assistant
• Production and Quality control testing of Radioimmunoassay kits
• Radioiodination of T3, T4 and TSH hormones.

Honors & Publications

Credentials

• Annual Product Quality Review (APQR)
• Post Market Surveillance Activities
• Introduction to Practical Statistics
• Introduction to GMP (Good Manufacturing Practice)

Awards

• GE Healthcare Award for an outstanding Health Canada GMP Audits
• GE Healthcare Silver Award for site QA compliance and leadership.

Publications 

• Comparison of Strontium in UK Hospitals                                                  
• Environmental radioactivity inter-comparison

Education

• B.S.   Degree, Chemistry, University of Madras, India