Ishrat Ali Qazi
Cockeysville,MD
Summary
Manufacturing supervisor professional with 20+ years of experience with extensive knowledge of cGMP requirements, auditing, root cause analysis, inspection readiness, and continuous improvement. Areas of expertise: review and execute the clinical and commercial manufacturing according to regulatory, site and client requirement. Final review of executed batch records and PLRs, increasing the ratio of value to non-value activities and eliminating waste in the overall production and supply chain while being held accountable for processes, personal, safety, compliance and meeting or exceeding the client requirements within operational areas. Driven by new challenges and desire to be successful in all endeavors.
Overview
27
27
years of professional experience
Work History
MANUFACTURING QUALITY ASSURANCE (ASEPTIC)
PII (PHARMACEUTICS INTERNATIONAL INC)
10.2023 - 10.2024
- Performed reviews of all operating processes and participates in internal quality assurance for the operations and facility.
- Performed record reviews while on the production floor.
- Participated in corrective actions of critical, major, or minor deviation found.
- Performed analysis of fill operation utilizing statistical process control software.
- Qualified as a visual inspector for performing AQL inspection subject to ongoing qualification training/testing.
- Performed qualification test for new employees and generate qualification report.
- Assures line clearances and appropriate quality procedures within the packaging areas.
- Responsible to see that all operation on the production floor is being performed as required by written procedure and participate in the writing and approval of these procedures.
- Assures critical steps have been performed as directed in SOPs and batch records.
- Demonstrates knowledge of production and support departments via the ability to perform, review and audit operations.
- Responsible for ensuring the MQA team operate safely and adhere to all regulations, policies, and procedure for health, safety and environmental compliance.
- Collaborate with cross-functional teams to address and resolve quality-related issues.
BLENDING SUPERVISOR
MEDIFAST INC
07.2019 - 07.2023
- Coordinated batch record review and approval process.
- Performed critical review of executed batch records.
- Execute and oversee the blending process.
Manufacturing/Packaging Supervisor
Wes Pharma Inc
09.2017 - 06.2019
- Performed line clearances and cleaning verifications for manufacturing and packaging operations as per standard operating procedures (SOP's).
- Performed in-process sampling, inspection, batch record review during and after completion of manufacturing/packaging processes as per SOP's.
- Performed powder and liquid fill weighing process as per manufacturing batch record (MBR) & cGMP
- Performed powder blending, blend sampling using thief & dies and data recording prior to submission.
- Performed liquid fill manufacturing and bottle filling, labeling, and packaging process.
- Performed setup and operation for pouch machine.
- Performed setup and operation for small cup filling machine.
- Supported annual product reviews (APR's) and created storage system for retrieval of retain samples for products.
- Performed investigation activities and prepared incident reports, investigation reports and planned deviation reports, as assigned.
- Engaged in planning activities to provide an effective support of manufacturing and packaging operations.
- Performed reconciliation and inventory calculations after completion of each process.
- Performed final review of batch records prior to submission to the QA.
MANUFACTURING/PACKAGING SUPERVISOR
PII (PHARMACEUTICS INTERNATIONAL INC)
12.2006 - 04.2017
- Coordinated batch record review and approval process.
- Performed critical review of batch records (BR) and packaging and labeling records (PLR) for release.
- Performed API and excipients weighing and gel mass weighing using WMS as required per batch record.
- Performed gel mass manufacturing, softgel capsules manufacturing and cream manufacturing as per batch record.
- Performed setup and operation for capsule inspection and polishing equipment.
- Performed setup and operation for capsule and tablet printers.
- Performed capsules and tablets packaging/labeling process.
- Performed final review of batch record prior to submission to the QA.
- Completed system application product (SAP) transactions which may include QA disposition of intermediate, Clinical, and commercial products for further manufacturing.
- Resolved complex issues in creative and effective ways using a wide range of experience, professional concept, and company objectives.
- Supervised evening shift for process continuation and successful completion.
- Performed training for new employees and retraining sessions for existing employees.
- Enforced company’s policies and procedure.
MED TECHNICIAN/LEAD MACHINE OPERATOR
BANNER PHARMACAPS, INC.
04.1998 - 06.2006
- Obtain batch record, collect raw material from warehouse, performed weight the ingredients.
- Performed mixing liquids and powders as per batch formula.
- Performed milling and deaeration process as required per the batch record.
- Transfer the finished fill to dispensing area for encapsulation process.
- Performed final calculation on batch record to verify the accurate completion of the batch.
- Operated encapsulation machine and troubleshooted the equipment as needed.
- Performed training for new employees and retraining sessions for existing employees.
- Enforced company’s policies and procedure.
Education
High School Diploma - undefined
Tameer-i-Nau High School
QuettaBachelor’s Degree - undefined
University of Baluchistan
QUETTASkills
- Creative Thinking
- Problem Solving
- Project Management-planning through execution
- Positive Client Relationships
- Excellent Communication: Written/verbal/interpersonal
- Team Oriented
- Time Sensitive Environment
- Microsoft Office (Word, Excel, PowerPoint, Outlook)
- Time Management
Training
- Introduction to cGMP | Health and Safety-Contamination and PPE |Documentation Practices
- Introduction to Health and Safety in the Workplace | Participation and Compliance of Workplace Harassment
- Introduction to Drug Development | Participation of Fire Extinguisher Training
Timeline
MANUFACTURING QUALITY ASSURANCE (ASEPTIC)
PII (PHARMACEUTICS INTERNATIONAL INC)
10.2023 - 10.2024
BLENDING SUPERVISOR
MEDIFAST INC
07.2019 - 07.2023
Manufacturing/Packaging Supervisor
Wes Pharma Inc
09.2017 - 06.2019
MANUFACTURING/PACKAGING SUPERVISOR
PII (PHARMACEUTICS INTERNATIONAL INC)
12.2006 - 04.2017
MED TECHNICIAN/LEAD MACHINE OPERATOR
BANNER PHARMACAPS, INC.
04.1998 - 06.2006
High School Diploma - undefined
Tameer-i-Nau High School
Bachelor’s Degree - undefined
University of Baluchistan
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