خالد عبد الرحيم  قاسم, Quality Assurance Supervisor

خالد عبد الرحيم قاسم

Quality Assurance Supervisor

Pharma Care KSA

البلد
المملكة العربية السعودية - جدة - السليمانية
التعليم
بكالوريوس, Analytical Chemistry
الخبرات
5 years, 6 أشهر

مشاركة سيرتي الذاتية

حظر المستخدم


الخبرة العملية

مجموع سنوات الخبرة :5 years, 6 أشهر

Quality Assurance Supervisor في Pharma Care KSA
  • المملكة العربية السعودية - جدة
  • أشغل هذه الوظيفة منذ يناير 2023

• Establish risk assessment studies relevant to the validation documentation.
• Responsible for Qualification of new facility and Equipment’s and Follow up overall validation activities
• Author, Review, execute process validation, Hold time Study protocols and validation summary reports.
• Author, Review, Execute Cleaning validation protocols and reports.
• Executed Qualification activities like IQ/OQ/PQ of all process related equipment’s.
• Perform validation testing and analyze data for validation documentation to determine acceptability.
• Responsible for ensuring and review of all calibration certificates in plant.
• Involved in assisting the QA Director, Quality Assurance to perform Quality Assurance Activities such as- Authors SOPs, Issuance, Distribution, Reviewing and controlling GMP documentation
• Responsible for training coordination as per training programmed Standard Operating Procedures
• Supervise and mange shop floor QA team for oral Powder & Liquid manufacturing areas
• Production oversight during validation events.
• Responsible for QMS throughout the plant and batch release system.

QA Senior Validation Specialist. في APEX Pharma
  • مصر - القاهرة
  • مايو 2022 إلى يناير 2023

Implementation and follow up of the validation and qualification systems.
• Author, Review, execute process validation, Hold time Study protocols and validation summary reports.
• Author, Review, Execute Cleaning validation protocols and reports.
• Review analytical method validation and Participate in the deviations, OOS investigations and audits.
• Review calibration plans, follow its execution and issue balances calibration plans and execute them. • Machines and equipment qualification and requalification.
• Issue and maintain annual validation master plan and validation protocols.
• Review calibration certificates and follow up execution of calibration plans.
• Responsible for ensuring the availability of all items through new product initiation check list.

QA IPC Specialist في Rameda Pharmaceutical Company
  • مصر - العلمين الجديدة
  • مايو 2020 إلى مايو 2022

• Conducting regular investigations to guarantee that workers follow safety procedures as required • Conducting quality audits as required to ensure compliance with GMP, Quality standards.
• Handling the pharmaceutical tailing waste according to the set rules and procedures in this regard.
• Carrying out material sampling as needed to conduct QA audits, checking samples conformity and taking decisions (Batch Release) of samples acceptance
• Performing pre- and post-production quality checks and providing related reports.
• maintaining GMP in manufacturing by 21 CFR compliance in shop floor equipment’s.
• Ensuring compliance of plant conditions (Humidity, Temperature, ΔP) with set guidelines and inspection on the gowning.
• Checking machine conformity to standards as well as ensuring periodic maintenance implementation
• Performing batch release, ensuring line clearance and in-process checks in shop-floor activities.
• Ensure that GMP Standards are followed properly in the Warehouse, Dispensing and manufacturing areas and during the manufacturing processes.
• Note: I’m working at this time at: Solids area (Tablet, Capsule, powder Filling and Sachet) / Sterile area (Eye drops and WFI) / Syrup area, and also, in non-sterile penicillin area.

QA Validation and Qualification Specialist في HETERO Multinational pharmaceutical company in its site in Egypt (Pharmed Health Care)
  • مصر - المنوفية
  • ديسمبر 2018 إلى مايو 2020

• Implementation and follow up of the validation and qualification systems.
• Author, Review, Execute Hold Time Study protocols and reports.
• Author, Review, Execute process validation protocols and validation summary reports.
• Author, Review, Execute Cleaning validation protocols and reports.
• Ensure the qualification for production machines / Lab equipment’s through conducting acceptance tests, installation qualification, operation qualification, performance qualification and requalification.
• Review analytical method validation.
• Review calibration plans, follow its execution and issue balances calibration plans and execute them. • Machines and equipment qualification and requalification.
• Issue and maintain annual validation master plan and validation protocols.
• Review calibration certificates and follow up execution of calibration plans.
• Participate in the deviations, OOS investigations and audits.

الخلفية التعليمية

بكالوريوس, Analytical Chemistry
  • في Faculty of Science, Menoufia university
  • مايو 2017

Graduated from Faculty of Science, Menoufia university (May 2017). • Bachelor of science (chemistry) department. • Cumulative grade: Very Good (honors).

Specialties & Skills

Process Validation
Cleaning Validation
Calibration
Quality Assurance
Good communication skills and negotiation skills.
Good presentation skills
Leadership and Management.
highly proficient in spoken and written English.
Analytical skills
Computer skills (Word, PowerPoint, Excel).
Committed to learning and development.
First class team player & problem-solving ability

حسابات مواقع التواصل الاجتماعي

اللغات

العربية
اللغة الأم
الانجليزية
متمرّس
الفرنسية
مبتدئ

التدريب و الشهادات

ICDL (الشهادة)
تاريخ الدورة:
May 2020
Six sigma Principles (الشهادة)
تاريخ الدورة:
August 2023
Executive Diploma in operations Management (الشهادة)
تاريخ الدورة:
August 2023
Sterile manufacturing systems (تدريب)
معهد التدريب:
Valor Academy
تاريخ الدورة:
May 2022
المدة:
48 ساعة
Qualification and Validation workshop (تدريب)
معهد التدريب:
Valor Academy
تاريخ الدورة:
March 2022
المدة:
48 ساعة
Lean Six Sigma Yellow Belt (الشهادة)
تاريخ الدورة:
December 2019
صالحة لغاية:
December 2022
Total Quality management (الشهادة)
تاريخ الدورة:
December 2019
صالحة لغاية:
December 2022

الهوايات

  • Watching Movies
  • Tennis
  • Freestyle Football