Senior QA Specialist

4 weeks ago

Hong Kong Island, Hong Kong SAR China Allergan Full time
Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Commercial Quality Specialist is responsible for independently providing Commercial Quality support in the affiliate. Scope of activities includes quality system requirements associated with: pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas of support may include Storage and Distribution, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. The Sr. Specialist has an in-depth knowledge of one or more elements and is considered a subject matter expert in these areas. This position will ensure that all product, process or system related quality activities supporting the business at the affiliate from receipt of final product through distribution are in compliance with Corporate, governmental, and local regulations and requirements.

  • Responsible for the integration of local quality regulations for drugs, biologics, device and/or combination products and cosmetics.
  • Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
  • Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
  • Plan, prepare, review and approve quality documentation such as change controls, product reviews and other local requirements.
  • Support internal, external and MoH audits as directed by the manager, lead self inspections.
  • Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.
  • Execute supplier qualification program including performance monitoring for key suppliers.
  • Monitor metrics and KPIs to ensure compliance.
  • Support all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments.
  • Support the Management Review process for the affiliate.

Represent Commercial Quality in cross functional teams, projects and programs, as assigned by management.

Qualifications
  • Bachelor's Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area preferred.
  • 3+ years experience in quality assurance, GMP or GDP environment preferred.
  • Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
  • Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics with an in-depth knowledge in one or more areas.
  • General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations.
  • Ability to support projects as a team member or lead as assigned by manager.
  • Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
  • Make decisions in collaboration with management.
  • Acts as an owner - uses available resources to independently complete assigned tasks.
  • Influencing - Understand your stakeholders and shape communication; can negotiate to win.
  • Personal Presence - Demonstrate the confidence that matches their subject matter expertise and intellectual capacity.
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html.

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more.

#J-18808-Ljbffr

  • Senior QA Specialist

    1 week ago

    Hong Kong Island, Hong Kong SAR China 海南澳美华制药有限公司 Full time

    About the JobWe are seeking an experienced quality assurance specialist to join our team. In this role, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.As a senior QA specialist, you will work closely with our regulatory affairs team to ensure that our products comply with relevant...

  • Mid-Senior QA Specialist

    4 days ago

    Hong Kong, Central and Western District, Hong Kong SAR China Ceffu Full time

    Ceffu, a leading institutional custody technology provider, is seeking a Mid-Senior QA Specialist to contribute to the development, testing and delivery of high-quality products.About Our CompanyWe offer a unique gateway to the world's deepest liquidity as the only institutional crypto custody partner of the Binance Exchange, providing world-class security...

  • Senior QA Engineer

    6 days ago

    Hong Kong Island, Hong Kong SAR China Classy Wheeler Limited Full time

    Classy Wheeler Limited invites applications for the position of Senior QA Engineer.About the RoleThis is a senior-level QA role requiring extensive experience in QA engineering.You will be responsible for designing, developing, and implementing automated testing frameworks.RequirementsAdvanced degree in Computer Science or related field.Minimum 8 years of...

  • Senior QA Analyst

    3 days ago

    Hong Kong Island, Hong Kong SAR China Classy Wheeler Limited Full time

    Senior QA Analyst (Manual / Automation) - ICClient DescriptionMajor digital and media broadcasting solutions provider in Hong Kong.Job DescriptionSenior QA Analyst (Manual)Candidates with less experience will be considered as QA Analyst.ResponsibilitiesEnsure the quality of media apps being used by millions of users globally and testing of applications on...

  • QA Specialist

    2 weeks ago

    Hong Kong Island, Hong Kong SAR China ConnectedGroup Full time

    QA Specialist - AI project - Financial Services (A026272) Central and Western District, Hong KongA leading financial institution is looking for a QA Engineer to support their AI project.Key Responsibilities:Design and implement detailed test plans and cases for AI systems and web applications, including chatbots.Develop and maintain automated test scripts,...

  • Senior QA Tester

    2 days ago

    Hong Kong Island, Hong Kong SAR China The Asian Banker Full time

    Key ResponsibilitiesThe successful candidate will assist and help the QA Team with pre-release testing & estimation (evaluating and communicating the risks to the QA Manager, colleagues and project stakeholders). They will also help drive the adoption of best practices, principles and ongoing improvement of the bank's existing Quality Assurance processes.

  • Senior QA Automation Engineer

    1 week ago

    Hong Kong Island, Hong Kong SAR China Wati Full time

    Job Description:We are seeking a highly skilled and experienced Senior QA Automation Engineer to join our team. As a key member of our software development lifecycle, you will be responsible for ensuring the quality and reliability of our products.Key Responsibilities:Develop and maintain automated test scripts using Selenium Framework Creation/Maintenance...

  • Senior QA Automation Specialist for Global Products

    7 days ago

    Hong Kong, Central and Western District, Hong Kong SAR China Tek Systems Full time

    Tek Systems is recognized as one of the largest American tech giants, and we are seeking a Senior QA Automation Specialist to join our global products team. This role offers a unique opportunity to work onsite at our headquarters and support key products, including an innovative AI Voice Assistant platform. Paid relocation to Hong Kong & Visa Sponsorship are...

  • Backend QA Specialist

    7 days ago

    Hong Kong, Central and Western District, Hong Kong SAR China Wonder Full time

    Wonder is seeking a skilled Quality Assurance Specialist to join our team.The ideal candidate will have experience in conducting software and product testing projects for various systems.You'll design, develop, and execute test plans and test data.Analyze test results, identify failures, and collaborate with the software engineering team to determine root...

  • Senior QA Engineer

    1 day ago

    Hong Kong, Central and Western District, Hong Kong SAR China Crypto Full time

    About UsCrypto.com is a leading global cryptocurrency platform serving over 80 million customers worldwide. Our mission is to empower people to control their financial destiny through innovation and technology.Key ResponsibilitiesAs a Senior QA Engineer, you will be responsible for:Designing and developing comprehensive test plans and test cases to ensure...

  • Senior Business Analyst

    6 days ago

    Hong Kong Island, Hong Kong SAR China Classy Wheeler Limited Full time

    Senior Business Analyst / Specialist (Testing QA) - ICClient DescriptionRenowned retail & eCommerce corporation in Hong Kong and regional.Job DescriptionSenior Business Analyst (Testing QA)Candidates with less experience will be considered as Business Analyst.ResponsibilitiesResponsible for the eCommerce solutions (website and mobile app) product change...

  • Lead/Senior QA

    2 weeks ago

    Hong Kong, Central and Western District, Hong Kong SAR China Hermeneutic Investments Full time

    As our Lead/QA Lead, you will be responsible for implementing and overseeing a standardized QA process across our teams. You will establish both manual and automated testing frameworks to ensure comprehensive test coverage for all our products, including systematic trading components where unit tests may be lacking. You will work closely with product and...

  • Software QA Lead

    3 weeks ago

    Hong Kong Island, Hong Kong SAR China ConnectedGroup Full time

    Software QA Lead - Typescript/Playwright/CypressOur client is an innovative tech start-up that helps businesses address key ESG and sustainability reporting challenges by combining advanced technology with expert advisory services. They support companies in over 40 countries across various industries in developing and enhancing their ESG strategies through...

  • QA Engineer

    2 weeks ago

    Hong Kong Island, Hong Kong SAR China Wati Full time

    WATI is an early stage, fast growing SaaS platform that is revolutionizing how companies communicate with their customers. Through our cutting-edge customer engagement software built on Whatsapp's Business API, businesses are now able to have personalised conversations, be easily accessible and engage with their customers in real-time - at scale We live in...

  • QA / Test Analyst – Investment Bank

    4 weeks ago

    Hong Kong Island, Hong Kong SAR China Darmax Global Full time

    Our client is a leading International Investment Bank with a collaborative and dynamic culture.The Role:This powerhouse is currently seeking an exceptional QA / Test Analyst to support the delivery of a new project initiative, Equity Trading Platform.Responsible for both functional and non-functional testing of various components.Design and execute test...

  • QA Engineer

    5 days ago

    Hong Kong, Central and Western District, Hong Kong SAR China GRIT Full time

    (Immed hire) QA Engineer (Manual Testing | tech platform) 1 day ago Be among the first 25 applicants Responsibilities: Assist in the QA process by conducting testing of software applications to identify defects, bugs, and usability issues. Contribute to the development and execution of test plans and test cases based on project requirements and...

  • Senior QA Automation Engineer

    2 weeks ago

    Hong Kong, Central and Western District, Hong Kong SAR China ConnectedGroup Full time

    Software QA Lead Job DescriptionConnectedGroup is an innovative tech start-up that combines advanced technology with expert advisory services to help businesses address key ESG and sustainability reporting challenges. They support companies in various industries in developing and enhancing their ESG strategies through technology.The company is seeking a...

  • Senior QA Engineer

    1 week ago

    Hong Kong Island, Hong Kong SAR China China Harbour Engineering Co. Ltd Full time

    Job DescriptionAs a Senior Quality Assurance Engineer at China Harbour Engineering Co. Ltd, you will play a key role in ensuring the effectiveness of our Quality Management System and ensuring compliance with requirements.Key Responsibilities:Act as QA Representative on project sitesAssist in the implementation and progress of our QMS to ensure its...

  • AI QA Engineer

    7 days ago

    Hong Kong Island, Hong Kong SAR China Pinpoint Asia Full time

    AI QA Engineer - Leading Financial InstitutionOur client, a leading financial institution, is seeking an AI QA Engineer to join their rapidly expanding digitalization team. This is an exciting opportunity to contribute to innovative initiatives, playing a key role in driving automation testing for cutting-edge AI projects before they reach end...

  • Senior IT Quality Control Specialist

    2 weeks ago

    Hong Kong, Central and Western District, Hong Kong SAR China Bank of China Full time

    About the RoleWe are seeking a highly skilled Sr. IT Quality Control Specialist to join our team. The successful candidate will assist the QA Manager in determining quality procedures, standards and specifications.Key ResponsibilitiesReview and improve the overall quality of deliverables.Support the QA Manager in writing QA reports and procedures.Coordinate...