QA Supervisor

QA Supervisor

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

As QA Supervisor, your will deliver QA operational performance. Your responsibility and deliverable are as follows:

• As Qualified Person, perform final batch record Review and Finished Goods Batch Disposition.

• Perform Quality oversight for manufacturing & supply activities.

• Ensuring and coordinating the implementation of updated Global QCM (Quality Compliance Manual) and applicable Regulatory Requirement and relevant Quality Management System applicable to Quality and Cikarang Site operations, including in developing and maintaining SOP/Work Instruction in QA area.

• Coordinate Deviation Management and Site Investigations, managing Site Investigator Qualification and Certification process, participate in problem solving or specific issues.

• Participates in the investigation of OOS and atypical events and/or quality issues placing particular attention to root cause analysis, technical completion and scope while ensuring accuracy of documentation contents, to ensure GMP and regulatory compliance.

• Coordinate Site Change Management, provide Quality review and assessment as QA Subject Master Expert.

• Coordinate Audit Management, i.e. developing Internal Audit Program, Internal Audit execution, support to all system owner in developing and monitoring Internal Audit CAPA.

• Monitor and track relevant Site CAPA, derived from Deviation, Change Control, Quality Risk Management, Lab Investigation, Qualification and Validation activities, Product Quality Review, Internal Audit, External Audit, GQA Audit and Regulatory Audit.

• Coordinate Site Quality Risk Management, including participate in the development and implementation of Quality Risk Assessments (QRA).

• Coordinate Validation and Qualification Management activities in AZ validation and qualification management system (i.e GVLMS) and ensure the qualification/validation status are maintained, developing Site Validation Master Plan, and ensure the Qualification and Validation execution as per the Site Validation Master Plan.

• Provide QA Support in Selection process of GMP supplier, maintaining the registration and status of Site GMP supplier in AZ Supplier Quality Management System, managing the QA Agreement, managing material complaint to supplier for any quality issue in incoming material and production activities, support or coordinating supplier visit and BRM-Quality as necessary.

• Managing and tracking all Product Quality Complaint receive from customer, both complaint IN and complaint OUT.

• Scheduling and managing Mock Recall Activity (i.e in Protocol Development, communication with stakeholder, monitor the execution, Mock Up Recall reporting).

• Managing implementation of GMP Training Management i.e ensuring Job Description and Personnel Qualification Training program and its documentation are in place and keep updated by each respective line manager, developing and coordinating the execution of Annual GMP Training Program.

• Develop and managing Product Quality Review Program.

• Managing communication with Global Stability team in developing and maintaining Site Stability Program.

• Document Control, Document Retention and Archival activities.

Essential for the role

• Bachelor’s degree in pharmacy and having apothecary degree

• Having at minimum 5 years’ experience in QA at Pharmaceutical company preferably in multinational company

• Familiar with quality system and implementation of GMP, GDP, and QC Standard

• Proficient in the GMP standard and regulatory requirements

• Excellent communication skill

• Good analytical skill and knowledge

• Fluent in English

• Computer literate

• Familiar with Application of Lean ways of working in QA environment.

Why join Operations at AstraZeneca?

We are driven by our commitment to deliver accelerated growth for AstraZeneca and to make people’s lives better. It pushes us to keep building on our foundations and progressing as we turn our ever-growing and increasingly complex pipeline from molecule to medicine. Be part of evolving how we work with Lean, cutting-edge science, digitalization and sustainable practices.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.

• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.

• If you’re curious to know more then please reach out to Aziza Fitriani. We encourage your application.

Where can I find out more?

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