Quality Assurance Specialist

4 months ago

Jakarta, Indonesia AstraZeneca Full time

Do you have expertise in Quality Assurance and a passion to play a critical role as the eyes and ears of our patients? If you have the passion and the drive to accelerate growth and make people’s lives better - then AstraZeneca is the place for you._

**ABOUT ASTRAZENECA**

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

At AstraZeneca, we unlock the power of what science can do. Empowered to explore, everyday we work towards our ultimate aim - treating, preventing, modifying and even curing complex diseases.

**BUSINESS AREA**

In Quality, our work is important and valued. An unrivalled forward-looking mindset, there’s no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products - discovery, development and commercialisation.

As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.

**What you’ll do**

Provides Quality Assurance support to an assigned area, including out of hours support. Develop, support, and drive excellence in MCOQ GMP & GDP Quality activities to maintain the local License to Operate. Serve as the primary point of GMP & GDP contact and maintain an effective governance structure to ensure oversight of quality activities. Non-supervisory, act as back up to MCOQ/QP for MC.

**General Accountabilities**:

- Is the responsible party for overseeing the design, implementation and delivery of a common Quality system and strategy for GMP and GDP activities across in Commercial marketing company for all of the AZ product portfolio in country.
- Participates in development of Global AZ MCOQ Quality Strategy and executes country strategy for MCOQ Quality and Marketing Company GMP/GDP aligned with AZ’s bold ambition strategy for market expansion, product launches and accessibility.
- Accountable for assurance of compliance with worldwide standards for all local GMP & GDP activities and connects the MC offices the broader Operations Quality and R&D organisation operating under One AZ QMS

**Typical Accountabilities**:

- Participate in defining the strategy for the commercial global markets and the execution of Affiliate GMP and GDP Quality System and framework in MC Indonesia.
- Define, develop, deploy, and monitor GMP/GDP policies and standards in MC Indonesia to ensure compliance with regulatory requirements.
- Ensure compliance assurance by working to one set of GMP & GDP standards and processes, including common GxP processes across the Affiliate GxPs.
- Support GMP & GDP activities impacting the MCOQ organization in the country.
- Support the Affiliate Quality Management Review process, preparation, execution, and escalations to senior leadership.
- Drive global standardization, simplification, and improvement of MCOQ Quality business processes.
- Develop and sustain a high-quality organization that continuously improves in competence, compliance standards, and innovative delivery of results.
- Provide training, support, and coaching related to Quality topics for Affiliate Quality network roles and MC Indonesia employees.
- Ensure country-specific regulatory requirements related to the manufacture and distribution of AZ products are met, including product release, issue management, recalls, and compliance with local regulatory agency interactions.
- Lead troubleshooting activities to resolve existing problems, make complicated judgments, and anticipate future developments in Quality-related needs.
- Manage Quality Standards and expectations across a broad range of services to provide high-quality, timely, and cost-effective service.
- Ensure adherence to Quality, Health, and Safety, GMP, GDP, and regulatory requirements.
- Carry out compliance reviews and reporting for external suppliers, including issue resolution with senior management and AZ site leaders.
- Prepare the country for Regulatory Agency and AstraZeneca inspections/audits, manage responses and to develop follow-up improvement plans to ensure ongoing compliance
- Support local MCOQ to deliver the license to operate, including GMP & GDP audits and inspections, and implement effective self-assessment programs.
- Ensure QMS compliance and continuous improvement in the country, with timely management and closure of issues.
- Promote a Quality Culture within MCOQ, setting strategy for GMP/GDP excellence in the region and locally.
- Achieve country KPIs and objectives/Quality Plans, and address trends through continuous improvement plans.
- Contribute to the development of procedures in the area of specialism and provide technical inpu

  • Supply Operation Quality Assurance Specialist

    1 month ago

    Jakarta, Indonesia Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Quality Assurance Specialist

    2 months ago

    Jakarta, Indonesia MSD Full time

    **Position Overview - Basic Functions & Responsibility** The following core responsibilities are generally applicable to the Quality Assurance Specialist (Quality Responsible Person) role in the country: - Ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good...

  • Quality Assurance

    1 week ago

    Jakarta, Indonesia Kone Full time

    Quality Assurance supports Quality Manager/Specialist to drive quality assurance in production or field operations. She/he identifies and analyzes improvement opportunities independently, prepares inspection plans and procedures and performs sample tests. Quality Assurance trains field or production operators and performs process audits. Job Description: -...

  • Quality Assurance Specialist

    1 week ago

    Jakarta, Indonesia Alterra Indonesia Full time

    Actively participate in walk-through, inspection, review and user group meetings for quality assurance Evaluate requirements, specifications and technical design documents to provide timely and meaningful feedback Design, create, and execute test cases within respective team to ensure quality Manage test environment creation & maintenance to ensure...

  • Training and Quality Assurance Specialist

    3 months ago

    Jakarta, Indonesia lalamove Full time

    Lalamove is disrupting the logistics industry by connecting customers and drivers directly through our technology. We offer customers a lightning-fast and convenient way to book delivery and moving services whether they are at their home, at work, or on the go. People talk about O2O, we live it! Our strength lies in our internal values, namely **Passion**...

  • Quality Assurance

    5 days ago

    Jakarta, Indonesia ForYourSolution Consultant Full time

    **ForYourSolution Consultant** founded on 7 September 2020., focused in Recruitmendt Agency (Headhunter), and HR Practioners (Psychological Testing, Coach and Counseling, E - Learning, Industrial Relationship, HR Management) Currently, our **Client** is looking for **Quality Assurance** **Requirements**: - Min. 2 years of experience as a **Quality...

  • IT Quality Assurance

    4 days ago

    Jakarta, Indonesia BitHealth Full time

    Create quality measurements to track improvement in products Execute quality improvement testing and activities Develop quality assurance standards and company processes Adhere to industry quality and safety standards Ensure products meet customer expectations and demand Create reports documenting errors and issues for fixing Work closely with the...

  • Quality Assurance

    2 months ago

    Jakarta, Indonesia Pasifik Sukses Gemilang Group Full time

    Quality Assurance - Gelar S1 di bidang Teknologi Informasi, Ilmu Komputer, atau bidang terkait - Pengalaman mínimal 2 tahun sebagai Quality Assurance di perusahaan teknologi atau pengembangan perangkat lunak - Menguasai metodologi pengujian perangkat lunak (manual dan otomatisasi) - Teliti, detail, dan memiliki kemampuan komunikasi yang baik - Berpengalaman...

  • Quality Assurance Officer

    7 months ago

    Jakarta, Indonesia Youtap Limited Full time

    **Join a dynamic and innovative team!** Youtap Limited is seeking a Quality Assurance Officer to ensure the highest level of quality for our software products. As a Quality Assurance Officer, you will be responsible for implementing and maintaining quality assurance processes and procedures to ensure optimal product performance and customer...

  • Quality Assurance

    7 months ago

    Jakarta, Indonesia OttoDigital Group Full time

    OttoDigital is part of Salim Group Digital Ecosystem (Financial Technology) - aims to empower “the underserved” and “the unbanked” population through integrated implementation of the Group digital payment ecosystem. We are digital platform and solution to businesses and enterprises, enabling various digital transactions on their services to better...

  • Quality Assurance Specialist

    2 days ago

    Jakarta, Indonesia PT 8 Elements Full time

    Manually identify and report bugs early Fully understand all of product requirement and technical implementation of 8elements products Creating test case, execute it then do the regression Identify things that can go wrong early but also quick to investigate bugs reported in production Report bugs clearly with all the relevant information to create...

  • Quality Assurance

    3 days ago

    Jakarta, Indonesia PT Personel Alih Daya (PERSADA) Full time

    Kualifikasi - Pria/Wanita max. 35 tahun - Minimal penendikan S1, semua jurusan - Pengalaman mínimal 2 tahun sebagai Quality Assurance di Contact Center - Kemampuan analisa dan Komunikasi yang baik - Computer Literate (Ms. Office, Access prefered) - Bersedia bekerja shift - Good typing speed Tanggung Jawab: - Bertanggung jawab untuk memastikan pelayanan...

  • IT Quality Assurance

    7 months ago

    Jakarta, Indonesia PT Bumi Amartha Teknologi Mandiri Full time

    Bumi Amartha Teknologi Mandiri or “AMARTEK” was established to provide information technology solutions. Our mission from the very first day has been to cultivate professional relationships with our clients to provide effective and reliable information technology solutions for their needs. The team at "AMARTEK" is equipped with a highly developed...

  • Quality Assurance

    1 week ago

    Jakarta, Indonesia PT Digital Informasi Futuristik Full time

    Quality Assurance - Hybrid (1 month 2x onsite in Jakarta) - Mininum exp 2 years especially in Quality Assurance Automation - Bachelor degree in Computer Science or related field form a top university - Able to Work Onsite in Jakarta - Domicile in Jakarta (is more value and priority) "Waspada terhadap Modus Penipuan pada saat proses interview. Perusahaan...

  • Software Quality Assurance

    6 days ago

    Jakarta, Indonesia PT Main Games Indonesia Full time

    **Responsibilities for Quality Assurance** - Create quality measurements to track improvement in products by creating a standard test case document for execution test - Execute quality improvement testing and activities (manual and automatic testing) - Develop quality assurance standards and company processes - Ensure products meet customer expectations and...

  • Quality Control Specialist

    3 days ago

    Jakarta, Indonesia SEVEN Retail Full time

    **QA/QC Specialist - SOZO Dental Clinic** **About the Role**: We are seeking a detail-oriented and proactive QA/QC Specialist to join our team. This role focuses on ensuring that all clinic conditions, including cleanliness and facilities, meet operational standards and align with regulatory requirements. If you have experience in quality assurance or...

  • Quality Assurance

    6 days ago

    Jakarta, Indonesia Lifepack.id Full time

    Quality Assurance - Minimum 2 years as a Software Quality Assurance (QA) Engineer - Good understanding of software engineering concepts - Have knowledge about agile and scrum - Experienced in testing a feature on multiple platforms and responsible for creating the entire test plan - Experience with bug tracking (JIRA), test case management (TestRail), and...

  • Quality Assurance

    2 hours ago

    Jakarta, Indonesia Impact Full time

    _**This position would require a yearly based-contract (1 year).**_ **About the Role** We believe in one integrated, easy-to-use, yet powerful software for all employees. We're looking for Quality Assurance to develop and implement quality testing methods of our software products. As a Quality Assurance, you will be involved in Impact’s product and...

  • Quality Assurance

    7 months ago

    Jakarta, Indonesia NTT Full time

    NTT is a leading global IT solutions and services organisation that brings together people, data and things to create a better and more sustainable future. In today’s ‘iNTTerconnected’ world, connections matter more now than ever. By bringing together talented people, world-class technology partners and emerging innovators, we help our clients solve...

  • Quality Assurance

    2 weeks ago

    Jakarta, Indonesia PT Bank BTPN Tbk Full time

    Assisting Quality Assurance (QA) activity in OLC Department regarding Operations GLs Follow up incomplete documents/data related to QA activities Admin and documentation related to OLC QA Assisting preparation of reports related to QA / OLC in general Accounting major Attention to detail Able to create report on presentation deck Proficient in Ms....