Rashedul Mossa Email & Phone Number

Raleigh, Nc, Us

Raleigh, North Carolina, United States

Enhancing quality operations at pharmaceutical client companies, consistently enabling them to remediate, renovate or expand operations in a fully compliant state, and to reduce costs. Help client with Project Management, Data Integrity, Six Sigma Methodology for Quality Engineering and Operational Excellency, Root Cause Determination, Deviation Management, Human Performance, Change Control Management, Quality Risk Management, Upstream & Downstream Process, Aseptic process, Corrective & Preventive Action/Effectiveness Check (CAPA/EC), Commissioning Qualification and Validation (CQV).

Grand Island, New York

• Led cross functional investigation team for root cause determination, developing corrective & preventive actions (CAPA) and effectiveness check plans (EC).• Performed quality risk management (QRM)/risk assessment. • Wrote manufacturing deviation investigation reports.• Reduced client’s backlog of investigations.

Mcpherson, Kansas

• Successfully implemented new quality management system (QMS).• Reduced a backlog of 400 manufacturing quality investigations, and increased product release per week through the new QMS.• Independently provide real time quality impact assessments and decisions (24/7) on drug product issues including manufacturing deviations. • Accurately assess consequences of decisions. • Accurately assess potential regulatory impacts on a global basis. Evaluate manufacturing deviations for FDA field alert requirement, and issue official notification to management if needed.• After initial assessment of Quality Assurance Reports and Events, transition remainder of investigation to others to complete write up as needed. Then manage investigations.• Take ownership of complex and critical investigation as needed, write investigation reports. • Perform quality risk management (QRM)/risk assessment. • Incorporate lean and six sigma tools. • Lead cross functional investigation team for root cause determination, for developing corrective & preventive actions (CAPA) and effectiveness check plans (EC).• Participate in Green/Black belt projects, RFT% Improvement projects.• Review and approve CAPAs, ECs, Standard Operation Procedures (SOPs) etc. • Independently assess a wide range of Change Control activities to determine potential Quality and Operational cGMP impacts.• Effectively communicate complex technical issues to all levels of Management (including outside of Quality). • Review and approve investigations for deviations. Perform Site Quality Approval of manufacturing quality assurance reports.

Hospira, A Pfizer Company. Mcpherson Kansas

• Ensure cGMP requirements, good documentation and other regulatory commitments.• Perform Laboratory Investigations. • Perform technical review of laboratory data packets for accuracy and completion. Provide quality approval for further processing of in process products.• Participate in review and update of standard operating procedures (SOPs).• Utilize expertise of instrumentation including UPLC, HPLC, GC, Particulate count analyzer, IR, UV, Karl Fisher Auto Titrator etc.• Train and oversee Chemist I in laboratory.• Perform process validations, manufacturing scale up and method transfers testing per protocols.• Perform stability studies of marketed drug products. • Collaborate with compounding and production line for on time quality release.• Perform standard qualitative and quantitative analysis on purchased raw materials, bulk, in-process and finished pharmaceutical products per control monograph and quality test methods.• Utilize problem solving techniques as needed.

Mcpherson, Kansas

1) Pharmaceutical API Storage Remediation:• Saved the plant annual labor cost of $150,000 by automation of monitoring system. • Minimized the risk of loosing high dollar API, loosing reputation to contract manufacturing customers, or receiving citation from regulatory agencies. • Led cross functional investigation team, and discovered root causes. • Led a remediation team to develop corrective and preventative actions (CAPAs).• Managed implementation of corrective and preventative actions.• Improved control storage monitoring system by innovative idea and automation. 2) DEA Compliance Project:• Analyzed and identified gaps for DEA compliance in chemical quality lab, raw material lab, and particulate lab. • Remediated gaps. Improved SOPs, documentation, storage, and handling of control substances.• Implemented 5S in storage locations. • Successfully made the department DEA compliant, and audit ready at any time.• Took over responsibilities to perform monthly and annual audits for control drugs.3) Employee health and safety incident investigation:• Acted as lead investigator for production workers' injuries during sanitation work in aseptic manufacturing areas. • Discovered root causes and developed preventative action plan.• Reduced number of Occupational Safety and Health Administration (OSHA) reportable injuries among aseptic sanitation crews.

Wichita, Kansas Area

- Cut client company’s marketing cost by half without compromising sales lead.- Managed overseas marketing operation.- Lead a team of 3 marketing employees. - Improved and optimized client’s marketing operation.

Wichita, Kansas Area

• Conducted research on novel catanionic vesicles aiming at their potential in various fields including protein-carbohydrate interactions, biotechnology and drug delivery.• Supervised undergraduate students in the research group.• Taught General Chemistry Laboratory Courses.

Wichita, Kansas Area

Wichita, Kansas Area

• Supervised a team of four business tax software customer support reps.• Researched IRS publications and internal resources to resolve customer issues that were elevated to supervisor.• Wrote queries/report for software limitation and bug fixes.

Master Of Science (Msc), Chemistry

Bachelor'S Degree, Chemistry

Activities and Societies: American Chemical Society, Student Government Association, Bangladesh Student Association, Sigma Phi Epsilon.