QA - Document Control Specialist

2 weeks ago


مصر, Egypt Orchidia Pharmaceutical Industries Full time

**وصف الوظيفة**:

- Issue, maintain, and design SOPs concerning the quality assurance department or other departments with common interfaces.
- Prepare and implement quality policies.
- Responsible for document control and record control activities.
- Issuing and distributing controlled documents and withdrawing the obsolete and invalid versions including approved procedures and SOPs, specifications, methods of analysis, batch records, protocols and plans.
- Perform all the required document updates for GMP documents for all departments.
- Prepare the list of the approved documents and preparing the document status on regular basis.
- Perform change control activities include assigning tracking numbers, routing, tracking, expediting change control, distributing new documents and retrieving obsolete ones, performing changes to text documents, and reporting on change control status to management.
- Participate in the implementation of the quality coding system.
- Follow up change control actions on the computerized system.
- Review specs (raw materials, primary, secondary packaging from quality control to release).
- Issue and create batch manufacturing records and batch packaging records.
- Assure all documents are reviewed for compliance with cGMP’s and company policies on periodic basis.
- Participate in the internal and external audits.
- Review and approve the specification of (raw material, primary packaging and secondary packaging and FP).
- Collect all department data related to SMF (site master file) from the machine list and utility list and QC machine list and organization charts and which are used in production, quality control, research and development, engineering and quality assurance.
- Review and approve the layout of the manufacturing and store and administrator site.
- Collect all department data related to quality manual or IMS (integrated management system) which matches with ISO standards.
- Issue and create media fill batch record and reviewing it with the batch manufacturing record to insure the media fill batch record mimics batch manufacturing in the process.
- Responsible for recall procedure investigation and to design of recall and inform all related destinations and make reconciliation and follow up the recalled quantity.
- Responsible for mock recall to mimic the actual recall.
- Responsible for receiving the complaint and investigating it and detecting root cause and putting corrective and preventive action.
- Receive the BOM of the packaging materials from the planning department to be checked for the correctness of the item codes.
- Participate in the documentation cycle of the validation activities.
- Responsible for following up on cGMP updates from different guidelines and reflecting them into the system in place by doing a gap analysis.
- Follow up, maintain and ensure implementation of safety instructions and requirements in certain areas.
- Work according to GLP, GMP and GDP rules.
- Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.

**المهارات**:

- Bachelor’s degree in pharmaceutical sciences or science.
- From 1 to 3 years of experience in pharmaceutical industry and operations.
- Understanding of methodologies and best quality assurance practices.
- Knowledge of documentation reviews and requirements analysis.
- Ability to troubleshooting and resolving complex issues effectively.
- Ability to work well through others.
- Ability to meet workloads and project deadlines.
- Excellent English, verbal / written communication.
- Excellent computer skills.

**المؤهلات العلمية**:
Pharmaceutical science or Science

**تفاصيل الوظيفة**:

- مكان الوظيفة- القاهرة, مصر- الدور الوظيفي- التصنيع- الحالة الوظيفية- دوام كامل- نوع التوظيف- موظف- يتطلب إدارة موظفين آخرين- لا- عدد الوظائف الشاغرة- 2**المرشح المفضل**:

- المستوى المهني- طالب/متدرّب- عدد سنوات الخبرة- الحد الأدنى: 1 الحد الأقصى: 3- الجنس- ذكر- الجنسية- مصر- الشهادة- بكالوريوس



  • مصر, Egypt Target Recruitment & HR Solutions Full time

    Don’t miss the opportunity in Cairo, Egypt, A “Document control manager” is needed to join a multinational company. **Job Description**: - Manages the document control department to ensure that processes comply with internal procedures and client requirements - Ensure that Projects/Department Milestones/Goals are met in a reasonably efficient...

  • Document Controller

    2 weeks ago


    مصر, Egypt Manufacturing Commercial Vehicles (MCV) Full time

    **Company**: MCV INDUSTRY ( egypt) - **Job Purpose**: Responsible for preparing and reviewing all the documentation related to purchasing tasks, in order to enhance the buyers’ performance by focusing on the main value-added tasks **Job Duties and Responsibilities**: - Complete and check FP documents of finance department such as insurance payment,...

  • QA Engineer

    2 days ago


    مصر, Egypt ILLA Full time

    We are looking for a dedicated QA tester to be responsible for designing and implementing test plans to improve the usability of our products. The QA tester works with the development team to debug code, correct errors, and troubleshoot any issues with the software code. A successful QA tester should be hard-working, have a strong working knowledge of...

  • Senior QA Officer

    7 days ago


    مصر, Egypt AstraZeneca Full time

    Putting down GMP SOPs, instructions and records. - Ensuring that QCM documents updates are reflected into AZ Egypt QMS, i.e compliance of local GMP documents with AZ GQA requirements. - Implementation of Policies, Procedures and all local and external regulatory requirements. - Prepare VMP and VMR - Technical support and review of change control records -...

  • Document Controller

    2 days ago


    مصر, Egypt lokma group Full time

    Coordinate, Receiving and distributing all documents -Archiving and keeping the assets of documents and the original documents -write internal memo -Perform other duties that maybe assigned to me by the Department. - Education: Bachelor Degree -experience : 0-1 years -very good computer skills ( word - excel ) (males only ) due to work conditions and timing...


  • مصر, Egypt Palladium Group, Inc. Full time

    **Export Documentation and Data Specialist** ***Primary Duties and Responsibilities**: Under the guidance and supervision of the NEEREs Technical Assistance Management, the Export Documentation and Data Specialist will support the TA team in documenting and archiving the execution of technical assistance and result-focused activities for all SMEs. This will...


  • مصر, Egypt TechnoHat Full time

    Create test plans and map requirements to test cases. - Review functional and design specifications to ensure full understanding of individual deliverable. - Write manual and automated test cases, preparing concise documentation. - Perform Quality Control by conducting manual and automated testing to find defects and assure that the product meets design...

  • Officer, QA

    23 hours ago


    مصر, Egypt Hikma Pharmaceuticals PLC Full time

    **Job Summary**: Responsible for performing basic tasks and some standardized routine testing and maintaining a high level of quality section services by monitoring and recommending solutions to quality-related issues under close supervision. - Ensuring compliance of manufacturing processes at Hikma plants with current Good Manufacturing Practices (cGMP) and...


  • مصر, Egypt Ray-Cro Full time

    Ensures that all quality Assurance - related activities surrounding a clinical trial are compliant with all regulatory requirements and ICH-GCP standards. - Establishing a document Control system and ensure compliance of SOPs with the local regulations & ICH-GCP. - Ensure that proper on the job Training Schedule is set to every employee in RAY - Responsible...


  • مصر, Egypt Viatris Full time

    3803 Viatris Egypt S.A.E At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless...

  • QA Engineer

    3 days ago


    مصر, Egypt RemotePass Full time

    We are a UAE-based startup, working remotely from all over the world. Our team is diversified and spread across 10+ different countries. We have the ambition to become a leading remote work enabler that simplifies the access to world class talents. We believe that anyone should be able to work anytime, anywhere. We are Backed by world class regional &...


  • مصر, Egypt Procore Full time

    What if you could use your technology skills to develop a product that impacts the way communities’ hospitals, homes, sports stadiums, and schools across the world are built? Construction impacts the lives of nearly everyone in the world, and yet it’s also one of the world’s least digitized industries, not to mention one of the most dangerous. That’s...

  • QA Coordinator

    2 days ago


    مصر, Egypt Viatris Full time

    Viatris Egypt S.A.E At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...


  • مصر, Egypt BayanTech Full time

    **Duties and Responsibilities**: - Responsible for calibrating, monitoring, and supporting the quality standards between internal and external parties. - Create process documentation/workflows/Work instructions, knowledge articles, and self-service guidance. - Collect and document business requirements for project and process improvement/automation...


  • مصر, Egypt Reno Systems LLC Full time

    **Junior Quality Control Engineer** **About the job** We are looking for a Quality Control engineer to develop and execute exploratory and automated tests to ensure product quality. Quality Control responsibilities include designing and implementing tests, debugging and defining corrective actions. You will also review system requirements and track quality...

  • Senior QA Analyst

    5 days ago


    مصر, Egypt AKQA Full time

    As a Senior QA Analyst, you will work closely with Technical Project Managers and Engineering team members to guarantee quality of delivery and ensure all digital agency outputs are aligned with key project success metrics. Located in Cairo, Egypt, as part of the AKQA team, you'll work in a meritocratic culture surrounded by some of the brightest minds in...

  • Lab Testing Manager

    2 days ago


    مصر, Egypt 00E1 - Grifols Egypt Plasma Der Full time

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...


  • مصر, Egypt FlairsTech Full time

    Details Required Experience 0-1 - Department R&D - Career LevelJunior Position Location Cairo / Alexandria **Skills**: Jira Research Skills Communication Team Work MS Outlook Microsoft Office Details Orientation Requirements and responsibilities The Data Migration specialist is responsible for migrating data from one Platform to another using ETL...


  • مصر, Egypt Parent ApS Full time

    (Remote Work - LOCATED IN EGYPT ONLY) We are looking for a qualified Quality Control Engineer. You will work on a diverse set of unique and challenging projects that allow users to seamlessly interact with technology.If you’re interested in creating a user-friendly environment and moving forward in your career, then this job is for you. We expect you to...

  • QA Engineer

    23 hours ago


    مصر, Egypt Procore Full time

    This role reports to the QA Manager and is based in Cairo, Egypt. We’re looking for someone to join our team immediately. **What you’ll do**: - Work with cross-functional teams to ensure quality throughout the software development lifecycle - Design and execute test cases - Verify that implemented software meets the business requirements - Suggest...