Loai Obeid
Quality Assurance Engineer
Amman
Summary
Quality Assurance Engineer with 3+ years of experience in the pharmaceutical industry, specializing in deviation management, CAPA systems, batch record review, and cGMP compliance within regulated manufacturing environments. Recognized for taking ownership of complex investigations and supporting quality system improvements. Strong expertise in root cause analysis, OOS investigations, in-process manufacturing oversight, secondary packaging oversight, and internal/external audit support. Proven ability to enhance quality systems, strengthen inspection readiness, and reduce recurring deviations. Committed to staying updated with evolving regulatory requirements, industry best practices, data integrity expectations, and pharmaceutical quality standards.
Overview
4
4
years of professional experience
2
2
Languages
Work History
Quality Assurance Engineer
Dar Al Dawa Development & Investment Co
10.2022 - Current
- Lead deviation investigations using structured Root Cause Analysis tools (5 Whys, Fishbone Diagram, and 6M’s) to identify systemic issues and prevent recurrence.
- Manage CAPA implementation and effectiveness verification to ensure sustainable corrective actions.
- Review and approve batch manufacturing and packaging records to ensure full compliance with cGMP and regulatory standards.
- Conduct OOS investigations in coordination with QC and production departments.
- strengthening deviation tracking systems to improve investigation closure timelines.
- Support enhancement of SOP control processes to ensure version control and regulatory alignment and suits the workflow.
- Participate in cross-functional quality meetings to identify recurring trends and implement preventive actions.
- Monitor manufacturing and packaging operations to ensure adherence to cGMP,approved SOPs, and regulatory requirements.
- Prepare, revise, and maintain QA SOPs in alignment with current regulatory updates and internal quality policies.
- Perform in-process control (IPC) physical testing and ensure compliance with product specifications.
- Support internal audits and regulatory inspections by ensuring documentation accuracy and inspection readiness.
- Participate in continuous improvement initiatives aimed at reducing deviations, improving documentation accuracy, and enhancing process efficiency.
- Ensured real-time implementation of approved batch manufacturing instructions, confirming all critical parameters remained within validated limits.
- Managed temperature and humidity excursions by conducting initial risk assessment, segregating affected materials, coordinating impact evaluation, and ensuring compliant storage conditions
- Immediate QA actions during incidents, including line stoppage when required, material quarantine, deviation initiation, and cross-functional communication.
- Assessed maintenance activities in production areas prior to line restart to ensure GMP compliance and proper documentation.
- Participated in GMP self-inspections and monitored adherence to data integrity (ALCOA+) and documentation practices.
- Implemented controls to prevent cross-contamination and mix-ups through strict line clearance verification, material identification checks, and area segregation.
- QA oversight during secondary packaging operations in accordance with approved packaging batch records.
- Performed pre-operation line clearance activities to prevent mix-ups and ensure correct product and artwork usage.
- Conducted reconciliation of bulk and printed packaging materials, verifying yield accuracy and investigating discrepancies.
- Review and approve packaging batch records prior to product release.
- Authorized transfer of finished products to the warehouse after confirming full GMP compliance and documentation completeness
- Maximized team productivity through continuous improvement initiatives and implementation of best practices in QA methodologies.
Analytical Chemical Engineer- Internship
Ministry of Energy and Mineral Resources
02.2022 - 06.2022
- Worked at Department of Chemical and Mineral on preparation
and analysis of Metal Oxides using XRF Spectrophotometer to
determine the percentage of elemental oxides in samples, ICO,
XRD, and methods of digestion and calibration used. - Worked at department of Organic Geochemistry on analyzing
using Fisher Oil Shale and using the Elemental (CHNS) Analyzer to
the ratio of Carbon, Hydrogen, Nitrogen and sulfur elements and
analyze the types of carbon from organic and inorganic TOC and on
the device for determining the calorific value resulting from burning
samples in geological samples in Bomb Calorimeter. - Prepared and processed samples using crushing, milling, and sieving equipment in accordance with laboratory procedures.
Education
Bachelor of Science - Chemical Engineering
04.2001 -
- Bachelor of Science in Chemical Engineering (ABET Accredited)
Skills
Deviation Investigation & CAPA Management
Root Cause Analysis (5 Whys, Fishbone, Risk-Based Thinking)
OOS / OOT Investigation
Batch Record Review & Release Support
GMP & Regulatory Compliance
SOP Development, Review & Training
Internal Audit & Inspection Readiness
Cross-Functional Coordination (QA, QC, Production, Warehouse)
Data Integrity (ALCOA)
Quality Risk Management
Additional Information
- Experienced in working within high-volume manufacturing environments.
- Strong ability to manage quality events under time pressure.
- Demonstrated cross-functional collaboration between QA, QC, Production, and Engineering.
- Familiar with JFDA regulatory requirements and stability protocols.
- member in ISPE (International Society for Pharmaceutical Engineering)