Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Languages
Timeline
Generic
Emad Al-Shorman

Emad Al-Shorman

Amman

Summary

Experienced and results-driven Quality Assurance Supervisor with over 7 years of hands-on experience in the pharmaceutical industry, specializing in sterile dry powder injectables, sterile eye drops, sterile eye ointments, non-sterile drops, and solid dosage forms. Proven expertise in implementing and maintaining GMP, cGMP, and regulatory guidelines (FDA, EMA, WHO, PIC/s) across diverse dosage forms and manufacturing environments. Skilled in batch record review, CAPA management, deviation investigations, media fill oversight, and quality risk assessments. Adept at ensuring regulatory compliance, driving continuous improvement, and fostering a strong quality culture. Strong knowledge of quality systems, change control, sterility assurance, and process validation. Committed to upholding the highest quality standards in support of patient safety and product efficacy

Overview

7
7
years of professional experience
1
1
Certification

Work History

Quality assurance supervisor

Savvy Pharma
08.2023 - Current
  • 1. Supervise and ensure compliance with GMP, cGMP, and regulatory guidelines throughout manufacturing, packaging, and storage processes of non-sterile solid dosage forms.
  • 2. Review and approve Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), equipment logbooks, and cleaning records to ensure accuracy, completeness, and compliance.
  • 3. Monitor and evaluate in-process controls (IPCs) during granulation, compression, coating, and packaging stages to ensure product quality and process consistency.
  • 4. Investigate deviations, non-conformance, OOS/OOT results, and coordinate effective CAPA implementation with cross-functional teams.
  • 5. Lead and document Quality Risk Assessments (QRAs), ensuring proactive identification and mitigation of potential quality issues.
  • 6. Coordinate change control activities, including review and follow-up of Change Control Requests (CCRs) and Document Change Control Requests (DCCRs).
  • 7. Ensure qualification, calibration, and maintenance of production and testing equipment in collaboration with engineering and validation teams.
  • 8. Monitor the proper handling and disposition of rejected materials, returns, and waste, and ensure traceability and compliance.
  • 9. Participate in internal audits, regulatory inspections, and readiness programs; address audit findings with comprehensive action plans.
  • 10. Collaborate with cross-functional teams (QC, Production, Engineering, Regulatory Affairs) to ensure a robust quality management system
  • 11. Track and report on quality KPIs, support continuous improvement initiatives, and escalate critical quality issues to management.
  • 12. Review and check documents generated by QA and GMP teams and any related documents generated by other departments.

Quality assurance /IPC supervisor

Amman pharmaceutical
10.2022 - 08.2023
  • 1. Supervise and ensure the implementation of GMP and quality standards across sterile manufacturing operations for eye drops, eye ointments, and non-sterile drops.
  • 2. Monitor daily production activities, including aseptic processing, filtration, filling, and packaging, to ensure compliance with regulatory guidelines and internal quality systems.
  • 3. Oversee environmental monitoring and ensure proper control of clean room behavior, gowning procedures, and aseptic techniques in classified areas.
  • 4. Review and approve batch production records (BPRs), cleaning records, and equipment logbooks to verify accuracy and compliance.
  • 5. Manage and investigate deviations, non-conformities, out-of-specification (OOS), and out-of-trend (OOT) results; ensure timely closure with proper root cause analysis and CAPA implementation.
  • 6. Support media fill (aseptic process simulation) and sterility assurance activities, including validation and periodic reviews.
  • 7. Ensure the qualification and calibration of production and testing equipment in coordination with engineering and validation teams.
  • 8. Monitor the release of raw materials and packaging materials, and supervise sampling, testing, and approval processes.
  • 9. Participate in internal audits, regulatory inspections, and readiness programs; address audit findings with comprehensive action plans.
  • 10. Collaborate with cross-functional teams (QC, Production, Engineering, Regulatory Affairs) to ensure a robust quality management system

QA officer

Pharma international company (PIC)/Axantia group
04.2018 - 09.2022
  • 1. Supervised aseptic processing operations within the injectable area, ensuring full compliance with GMP standards and aseptic techniques.
  • 2. Monitored all production stages, reviewed and approved batch record documentation, and ensured adherence to SOPs and GMP protocol.
  • 3. Ensured documentation and equipment met all relevant quality and regulatory standards.
  • 4. Verified product conformity through approved sampling and inspection procedures at various production stages.
  • 5. Conducted in-process control (IPC) testing during manufacturing stages and coordinated chemical analysis with appropriate laboratories.
  • 6. Assist related departments in withdrawing samples from the cleaned equipment to be analyzed in the related laboratory.
  • 7. Ensured compliance with GMP and quality standards across manufacturing, packaging, and storage facilities.
  • 8. Investigated deviations and customer complaints, ensuring proper documentation and timely closure.
  • 9. Participated in media fill (aseptic process simulation) activities and validated interventions for sterile dry powder products.

Education

Bachelor's Degree - Biology

Hashemite University
08.2017

Skills

  • Ability to Multitask - Experienced
  • Communication Skills - Experienced
  • Leadership Skills - Skillful
  • Ability to Work in a Team - Skillful
  • Risk assessment - Skillful
  • Reporting - Skillful
  • Inspection Handling & Response - Skillful
  • Training & Quality Culture Development - Skillful
  • Quality system development

Accomplishments

  • perform contamination control strategy for sterile lines

  • lead aseptic process simulation for sterile dry powder , eye drops and eye ointment

  • perform a shared facility risk assessment

  • perform a manufacturing process risk assessment for sterile lines

  • perform a risk assessment for manufacturing of non antibacterial beta lactam compound and hazardous products.

  • perform a risk assessment for new warehousing area

  • Deviation & CAPA Management

Certification

  • ISO 9001 lead auditor - SGS, July 2024 – July 2024
  • Eu.GMP annex 1 update and application - PharMatrix for training and consultation, May 2023 – May 2023
  • Good distribution practice - Zonetechs for consulting & training, May 2025 – May 2025

Languages

English
Intermediate (B1)
Arabic
Bilingual or Proficient (C2)

Timeline

Quality assurance supervisor

Savvy Pharma
08.2023 - Current

Quality assurance /IPC supervisor

Amman pharmaceutical
10.2022 - 08.2023

QA officer

Pharma international company (PIC)/Axantia group
04.2018 - 09.2022

Bachelor's Degree - Biology

Hashemite University

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Emad Al-Shorman