Ext. Supply Quality Assurance Manager
4 days ago
Responsible for managing quality aspects at external suppliers for Biopharmaceuticals /Pharmaceuticals/Devices and to ensure that the operational business is in compli-ance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quali-ty Manual and is conducted according to the relevant SOP's.
- Lead External Suppliers Qualification process
- Act as Single Point of Contact/SPOC for all quality related activities at the External Supplier
- Ensure that all aspects of the handling. manufacturing and distribution of biophar-maceuticai/pharmaceutical products are in compliance with the Novartis Pharma Quality Man-ual, the effective Quality Agreement. that they meet relevant cGMP regulatory requirements and are conducted according to local SOP's
- Responsible for driving/initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps in Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execution is to be monitored to ensure that issues are suitably addressed
- Provide the quality presence and in-put to Technical Meetings with the External Suppliers and establish good working relationships with clear communication and de-fined actions and goals
- Ensure that a valid QA Agreement defined on line with the requirements Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the Exter-nal Supplier, as well as Product details and requirements
- Request, review and process GMP documentation as defined by the Quality Agreement and Novartis SOP's. Manage the quality aspects of the relationship in accordance with the effec-tive Quality Agreement. Perform the required periodic review and make recommendations for amendments to the agreement based on identified needs and issues
- Responsible for coordinating and ensuring that Quality auditing of External suppliers is car-ried out according to the Novartis Quality Manual - maintain an annual auditing program. par-ticipate in and/or lead audits. manage action plans and follow up on agreed upon CAPA's. Ensure site readiness for regulatory inspections at External sup-pliers where appropriate
- Manage all critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual. Ensure investigations are correctly executed
- Support/participate in Novartis Emergency Management cases as required
- Ensure that Change requests, either from the External Supplier or from Novartis, are managed according to the Quality Agreement and Novartis SOP's from receipt, through to the imple-mentation and closure
- Responsible for assessing quality trends and driving continuous improvement for process and product quality performance
- Ensure that the External Supplier provides the required product review or the data as speci-fied in the relevant Quality Agreement on an annual basis. Critically assess the performance of the product and process and provide the assessment to the report annually
- Escalade any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required within the organization.
- Support the implementation and maintain a local Quality System and Standard Operating Procedures defining all the processes for managing of External suppliers
- Ensure that the External Supply Global QA Head and the Supplier Relationship Man-ager are kept informed of all critical and major issues which may have an adverse effect on the quality of the product at an External Supplier
- Together with the Supplier Relationship Manager provide direction, formulate strategies and make decisions which ensure the efficient operation of the External Supplier business as a whole - Participation in the Business review of External Suppliers
- Participate in the Reporting on QA External Supplier activities - this is to include Risk As-sessment, reporting and managing of defined KPl's
- Ensure that coordinated contact is maintained with other functions within Novartis also deal-ing with External Suppliers namely Purchasing, Legal, Supply Chain, Regula-tory CMC, Drug Regulatory Affairs, Group Quality Operations (GQO), etc
- Participate in the ESO Quality Plan - ensure that all quality issues at External Suppliers are included in this plan Participate in projects as defined and ensure that all aspects are imple-mented and followed up
- Personal Development
- Maintain current knowledge of local and international regulatory and legislative requirements and trends
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- Education (minimum/desirable): Pharmacy graduate ,
- Languages: French : Fluent (mandato
-
External Supply Quality Assurance Manager
4 weeks ago
مصر, Egypt HEXAL EGY Full timeSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...
-
Quality Assurance
2 weeks ago
مصر, Egypt Informa Markets Full timeCompany Description Informa is the world’s leading business intelligence, academic publishing, knowledge and events business. We serve customers in many different industries, from Life Sciences to Finance, Education, Agriculture and TMT. Listed on the London Stock Exchange and a member of FTSE 100, with over 10,000 colleagues working in more than 30...
-
Supply Chain Manager
4 weeks ago
مصر, Egypt SSC Egypt Full timeDesign and implement supply chains that support business strategies adapted to changing market conditions, new business opportunities, or cost reduction strategies. - Develop procedures for coordination of supply chain management with other functional areas, such as sales, marketing, finance, production, and quality assurance. - Manage activities related to...
-
Quality Assurance Manager Banking
5 days ago
مصر, Egypt Expleo Full time**Responsibilities**: - Develops strategies and directs teams with diverse scope. - Ensures that project deliverables are completed within agreed cost, timescale and resource budgets, and are signed off. Proactively aims to achieve personal and team utilisation targets. - Uses project planning tools and participates in the identification of and planning for...
-
Quality Assurance Engineer
7 days ago
مصر, Egypt Avelabs Full time**Job description** - Understand organizational standard processes and procedures in addition to supporting Team Members in their understanding and implementation. - Evaluate the adherence of projects' processes and work-products in accordance with set Avelabs standard processes. - Plan and Perform quality assurance review audits. - Follow up quality...
-
Quality Assurance
4 weeks ago
مصر, Egypt Expleo Full timeOverview: **Responsibilities**: - Develops strategies and directs teams with diverse scope. - Ensures that project deliverables are completed within agreed cost, timescale and resource budgets, and are signed off. Proactively aims to achieve personal and team utilisation targets. - Uses project planning tools and participates in the identification of and...
-
Sales Quality Assurance
5 days ago
مصر, Egypt iSchool Full timeiSchool is currently seeking a detail-oriented and experienced Sales Quality Assurance specialist to join our team. As a Sales Quality Assurance specialist, you will play a critical role in ensuring the quality of our sales processes and customer interactions. You will be responsible for monitoring and evaluating sales calls, providing feedback and coaching...
-
Quality Assurance Engineer
2 weeks ago
مصر, Egypt Luxoft Full time**Project** Description**: - Delivery Quality monitoring team is a dedicated quality group with three major responsibility areas: - Software engineering process establishment and improvement (including ASPICE assessments and tailoring of the standard process) - Quality assurance (process and work product auditing) - Tools and technologies (maintenance,...
-
Quality Assurance Team Lead
2 weeks ago
مصر, Egypt BlackStone eIT Full time**Daily and Monthly Responsibilities** - Lead, mentor, and manage the quality assurance team to achieve departmental goals and objectives. - Develop and implement quality assurance strategies, policies, and procedures to ensure effective and efficient testing of software products. - Establish quality standards and best practices for software development and...
-
Quality Assurance Associate Manager
4 weeks ago
مصر, Egypt Majid Al Futtaim Full timeMajid Al Futtaim Holding is the leading shopping mall, retail, communities, entertainment developer and operator in the Middle East, North Africa, and Central Asia regions. With over 48,000 people, revenues of over US$ 11 Billion, and operations in 18 countries. Some of the iconic brands we carry include Mall of the Emirates, Carrefour, All Saints, Lego,...
-
Quality Assurance Engineer
4 weeks ago
مصر, Egypt SamTech Group Full timeWe are looking for a Quality Assurance Engineer to ensure the quality of our systems. You will be responsible for developing and executing tests to identify issues and improve product quality. **Responsibilities**: - Develop and execute test plans, test cases, and test scripts. - Perform functional, regression, and performance testing. - Identify,...
-
Sr. Quality Assurance Manager
4 weeks ago
مصر, Egypt Alorica Full time**GET TO KNOW ALORICA** At Alorica, we only do one thing - make lives better, one interaction at a time. We're a global leader in customer service and experience, serving the world's biggest brands with tens of thousands of employees in hundreds of locations around the globe. **JOB SUMMARY** Responsible for developing, managing, and coordinating quality...
-
Senior Quality Assurance Engineer
4 days ago
مصر, Egypt Curenta Full timeWe are looking for a Quality Assurance Engineer to develop and execute exploratory and automated tests to ensure product quality. Curenta is a digital health-tech startup changing the shape of long-term healthcare through medication delivery innovation. If you are excited to join an ultra-growth startup that is quadrupling its growth every month since the...
-
Quality Assurance Specialist
19 hours ago
مصر, Egypt EGBank Full time**MAJOR RESPONSIBILITIES AND ACOUNTABILITIES** - Visit EGBANK branches regularly to monitor and ensure quality measures are preserved and continuously improved across all activities of customer service. - Discuss the Branch visit’s findings with the branch manager; provide counselling to improve the branch imac ge and level of service. - Submit the...
-
Quality Assurance Director
2 days ago
مصر, Egypt EWI Recruitment Full timeA well-known tier one major Construction contractor is looking for a Cooperate Quality Assurance Quality Control Director to be based in Cairo Egypt and directly report into the CEO. The Cooperate Quality Assurance Quality Control Director oversee the overall Quality Policy and take off responsibility regarding the Quality Strategy to take all decisions...
-
Supplier Quality Assurance Manager
1 week ago
مصر, Egypt Beyti Egypt Full timeLead supplier/co-manufacturing development strategy, designing the metrics for the function and supplier performance. - Develop and improve supplier co-manufacturing capability for raw materials/ intended products quality in line with applicable standards (if needed by site team) in order to improve material quality performance in operation ensuring that...
-
Head of Quality Assurance
19 hours ago
مصر, Egypt InstaShop Full timeInstaShop, headquartered in Dubai, is the leading online marketplace for supermarkets, pharmacies, pet shops & other businesses in the Middle East. With a young & motivated team & an office resembling the ones of startups in San Francisco, InstaShop is the right company for individuals passionate about adding value within a fast-growing technology...
-
Quality Assurance Supervisor
4 weeks ago
مصر, Egypt General Motors Full time**Job Description**: As the **Quality Assurance Supervisor **you will be responsible for specifying requirements, execution and evaluation of designs, analysis, development, testing and control of major engineering projects where your creativity and initiative are involved as well as a high level of independent judgment. Exercises technical direction over...
-
Quality Assurance
4 weeks ago
مصر, Egypt xpendless Full timeFarhan RashadShadi Hudaifa (Xpendless) please review the modified version **Job Title: Quality Assurance (QA) Specialist** **Location**: Remote **Company**: Xpendless **About Us**: Xpendless is a pioneering fintech solution based in Qatar, empowering businesses of all sizes with seamless expense management and prepaid cards. As the first and only...
-
Quality Assurance Inspector
4 weeks ago
مصر, Egypt Kontoor Brands Full timeWho We Are: Kontoor Brands, Inc. (KTB) is the parent company of Wrangler®, Lee® and Rock & Republic®, with owned manufacturing facilities in Mexico and Nicaragua. Kontoor also owns and operates over 140 retail stores across the globe. Our global company employs more than 15,000 people in 65 countries, with world headquarters in Greensboro, North Carolina,...