Neelma J. Email & Phone Number

Gaithersburg, Maryland, Us

• Performed validation of complex automation systems such as Siemens PCS7, Delta V, GMPH and BMS. • Performed validation of biopharmaceutical pieces of equipment including temperature mapping by using Kaye Validator 2000 and various wireless Data Loggers for validation.• Reviewed and approved validation related system lifecycle design documentation (User Requirements, functional and design specification, commissioning and qualification protocols).• Developed / executed and reviewed validation test plans and protocol consistent with site procedures and practices• Performed equipment, aseptic processing, steam sterilization, cleaning validation and process validation and their associated control systems• Possess Strong knowledge of validation and related practices, including governmental regulations. • Demonstrated success in technical proficiency, creativity, and collaboration with others and independent thought. • Developed/executed and reviewed validation test plans & protocol consistent with site procedures and practices• Performed equipment, aseptic processing, steam sterilization, cleaning validation and process validation and their associated control systems• Managed Validation Activities within timelines commitments including development a plan with timeline, deliverables, and accountabilities• Represented validation on projects and in addressing issues. Develop and recommend solutions outside general practices with a focus on continuous improvement and compliance • Developed system that promotes and results in improved efficiency within the department and company• Summarized major project validation activities in reports• Represented validation on internal teams, committees.

Lexington, Ky, Us

• Established and maintained a system to control cGMP documents and records.• Reviewed all data, calculations, and attachments in executed batch records, operational records and cleaning records. • Reviewed QC laboratory records, data and calculations for in process and final lot testing.• Approved and or rejected materials, components, starting materials, intermediate products, final API, and drug product used in manufacturing, packaging and shipping. • Assured starting materials, intermediates, API, and drug products were manufactured and tested in a manner consistence with the applicable regulatory filing(s).• Responded to client questions and request concerning executed and reviewed batch production records and test packaging• Reviewed and approved:o Validation protocols and validation reportso Scientifically sound reports for test methodso Protocols, Time Pointe Testing and final report for stability studies.o Deviations, non-conforming material investigation reports, out of specification test results and formal investigation.o SOPs impacting quality of intermediate or API

Midland, Michigan, Us

• Prepared and executed validation documents i.e., IQ, OQ, PQ for equipment, processes, cleaning, building, QC Lab, Micro Lab and software validation. Completed PCS 7 computer validation for an API automation project.• Completed Six Sigma Black Belt project to improve QC lab on time delivery matrix.• Generated test data and documentation for validation to provide high degree of quality assurance for API, and medical device manufacturing.• Approved documents prepared by vendors and manufacturing engineers. • Performed clean room and incoming inspection area validation.• Assessed Process Change Requests (PCR) for impact on validation status, as well as interpreting regulatory standards as it applies to the site.• Provided responses to the FDA audit findings, customers and other regulatory agencies. • Reviewed and prepared validation master plan, site validation policies and procedures for the Healthcare Industry Material Site.• Trained site manufacturing engineers for process validation requirements. • Assisted in investigation for internal and external complaints and recommended corrective action. • Performed aqueous and non-aqueous cleaning validation for API and medical device component manufacturing and risk assessments to capture critical changes. • Performed risk assessments to capture critical changes.

Dublin, County Dublin, Ie

• Performed cleaning validation for liquid and solids manufacturing, analytical testing to resolve cleaning failures and improved cleaning validation program for three plants in Michigan.

New York, New York, Us

Ran global clinical studies, managed global supplies from manufacturing to clinical sites, and managed clinical projects and clinical database globally.• Ensured on time delivery with accurate initial and continuing supply of pediatric cancer treatment drugs enabling clinical trials in five different countries.• Executed on time shipments by forecasting and using TcVisualize, Clinicopia, IVRs, M3, GDMS, PTRAC, CSDS systems and MS projects to effectively run studies globally.• Met critical deadline that enabled continuation of study at 24 sites in seven countries by developing and distributing an accurate dosing label for a pediatric clinical trial.• Forecasted and met requirements to initiate a protocol for an 18-month period by collaborating with Regulatory CMC, Clinical Manufacturing, Clinical Packaging, PharmSci QA, Dev Ops, and Inventory Management.

New York, New York, Us

Coordinated manufacturing activities for clinical batches in Ann Arbor. Coordinated manufacturing activities for clinical batches. Represented Clinical Manufacturing on technical and project management aspects on cross functional teams.• Generated project plans and timelines for manufacturing campaigns by partnering with SCM scheduler and manufacturing supervisors. • Reviewed batch documentation pre and post manufacturing.• Generated Master Batch Records (MBR), Working Batch Records (WBR), and all associated forms and labels required for execution and trained technicians on the batch records prior to execution.• Ordered components, API, and excipients from the warehouse for manufacturing.• Prepared experimental batch records and authored Dosage Material Identification Sheet (DMID) and Master Batch Records (MBR) for GMP.• Supported processing of GMP batches and provide oversight when required.• Managed multiple projects and assisted in outsourcing with third party manufacturing.

New York, New York, Us

Coordinated cleaning validation/verification activities for pharmaceutical GMP equipment according to internal and FDA standards.• Performed required cleaning validation on all manufacturing equipment; ensuring previous drug removal according to internal and FDA standards.• Collaborated with Quality, Analytical and Formulating groups during all phases of the cleaning validation program.• Served on a committee charged with revamping and globally harmonizing the cleaning validation program that ensured compliance with FDA and other agency regulations.• Supported clinical batch production through timely release of quarantine equipment.• Provided training to compliance group members on appropriate swabbing techniques. • Conducted bi-weekly safety and cGMP inspection rounds which identified and maintained a conforming work environment

New York, New York, Us

• Executed batch records to manufacture tablets and capsules.• Conducted physical in-process testing and efficiently operated solid dosage manufacturing equipment.

New York, New York, Us

Pfizer Gum Department ADAMS now known as Cadbury. Worked on Tecdoc and development of new gum. Processed Gum formulas that included babaloo, dentyne and chiclets.