QHSE Manager.
Tadbeir Operations & Maintenance
مجموع سنوات الخبرة :12 years, 11 أشهر
Responsibilities:
Design, Implement an Effective QHSE Management System.
Improve the internal documentation system.
Develop an internal training program to maintain high qualification and competency levels for personnel regarding quality principles and technical skill.
Managing KPIs objectives with all KSHs effectively.
Achievements Highlights: -
Build up a robust QHSE Management system for King Abdullah Financial District project.
Deliver NLT 150 training Hrs. for each individual started the project including QHSE, technical & soft skills topics.
Achieve project QHSE deliverables through 3 years, which has been reflected in a satisfactory KPIs scores without deductions from dues, leads to business enhancement and extension of scope of work.
• Lead the governance & the organization structuring project through applying the applicable
methodologies IFAS, EFAS, SWOT, and PESTLE Analysis.
• Develop the company vision, mission, policies, strategies, programs, and procedures.
• Lead the digitalization project by applying QHSE processes on MAXIMO System.
• Design, Implement Effective QHSE Management System.
• Develop an internal training program to maintain high qualification and competency levels for
personnel regarding quality principles and technical skills.
• Conducting internal audits & Managing KPIs objectives with all KSHs effectively.
• Lead six sigma projects to save costs & increase efficiency.
Responsibilities:
Assure ongoing compliance with quality and industry regulatory requirements.
Participate, prepare and lead internal and external audits.
Quality & GMP Training for the Region.
Coordinates and manage GXP vendors including audits and vendor qualification packages.
Deviation investigation, CAPA creation, review, close-out.
Prepare reports to communicate outcomes of quality activities.
Draft Novartis site quality Agreements.
Conduct quality management review.
Complete KPI Score cards and signoff on all sites included in the region.
Achievements Highlights: -
Deliver comprehensive GMP training for all the team in the region.
Achieve project quality deliverables, which has been reflected in a satisfactory KPIs scores without deductions from dues.
Accomplish 100% of qualification for vendors.
Conduct two internal audits and two management reviews.
Responsibilities:
Oversees performance of laboratory staff in compliance with accreditation standards “CAP, College of American Pathologists”, safety and environmental regulations, and other applicable requirements.
Manages quality monitoring, improvement programs, providing appropriate education and training.
Preparation of periodic reports of quality issues, trends, findings, and corrective and preventive actions.
Develops and produces Standard Operating Procedures (SOP’s) which meet the regulatory/accreditation standard.
Liaison with suppliers, service providers and external parties for quality issues.
Completes and submits the required documentation for accreditation process.
Review hygiene programme and ensure proper implementation.
Plan, establish, execute, measuring and continuously improve calibration, risk, supplier qualification management systems.
Achievements Highlights: -
Improve efficiency of established calibration management system.
Participate in preparing for CAP audit, and accreditation renewal.
Responsibilities
Lead team responsible for handling the following processes: -
Deviation, CAPA, change control, complaint, internal audit, risk assessment, recall, APR & supplier qualification.
Participate in problem solving and root cause analysis for raised deviations & complaints and follow CAPA implementation and measuring its effectiveness.
Liaison with suppliers, service providers and external parties and participate in preparing for, coordinating and following external audits conducted by statutory and regulatory parties as MOH, ISO certification body and other customers as GSK, MUP, Sanofi Aventis and Pfizer…
Define training needs and train all staff on previous processes then evaluate and assess training impact.
Achievements Highlights: -
Lead compliance team to pass 8 audits effectively.
Reduce deviation rate through comprehensive investigation, proper root cause analysis and effective CAPA implementation up to 40% annually.
Responsibilities:
Planning, establishing, executing, monitoring and continuously improving deviation and CAPA management systems to be consistent with regulatory, statutory.
Achievements Highlights: -
Include root cause analysis techniques in deviation management process.
Preparing monthly trends and semiannual reports revealing effectiveness of deviation / CAPA systems, and disclose weakness and opportunities to improve QMS.
Appreciation letter as a member of the team who was responsible for planning, executing and operating the new ampoule project which involve adding two new production lines.
Responsibilities:
Inspect storage and distribution of pharmaceutical products (RM & FP) in OTSUKA warehouses against GSP &GDP requirements.
Inspect CIP/SIP for machines and facilities.
Inspect production lines/areas (Raw material receiving, dispensing, preparation, filling, sterilization, inspection, packaging) against GMP requirements and OTSUKA SOPs.
Check personnel hygiene and sanitation status.
Participate in validation activities (as HVAC validation, sterile room validation, Cleaning Validation, SIP validation, media fill test ….) and issue, review validation documentation system.
Controlling tablet IPC tests as friability, disintegration, hardness, thickness and weight variability.
Check sampling and testing of product during product life cycle according to approved sample plans.
Complete and maintain quality and production records according to GMP and other quality standards & Batch Record Review.
Responsible for marketing blood-glucose measuring dev ice “Free Style” in hospitals and
private clinics.
Good