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.
What you'll do
General Accountabilities:
- Perform batch record Review and issuance.
- 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.
- Participate in Deviation Management and Site Investigations, and in problem solving or specific issues
- Participate in Site Change Management, provide Quality review and assessment as Subject Master Expert under appointed Quality Assurance area of responsibilities.
- Participate in Site Audit Management, i.e. support to ensure Internal Audit Program is executed, provide 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.
- Participate in Site Quality Risk Management, including participate in the development and implementation of Quality Risk Assessments (QRA).
- Participate in Validation and Qualification Management activities in AZ validation and qualification management system (i.e GVLMS) and ensure the qualification/validation status are maintained, 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
- 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, coordinating the execution of Annual GMP Training Program
- Managing Product Quality Review Program
- Document Control, Document Retention and Archival activities
This role is a maternity leave replacement and will be hired on a contract basis under a third-party vendor.
Essential for the role
- Bachelor's degree in pharmacy and having apothecary degree
- Having 1-3 year experience in Pharmaceutical company in Quality activities is preferable
- Familiar with quality system and implementation of GMP / CPOB standard
- Proficient in the GMP standard and regulatory requirements
- Excellent communication skill and digitalization.
- Good analytical skill and knowledge
- Fluent in English
Why AstraZeneca
Here you'll have the opportunity to make a meaningful difference to patients lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.
With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There's no better time to join our global, growing enterprise as we lead the way for healthcare and society.
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 welcome your application.
Where can I find out more
Our Social Media, Follow AstraZeneca on LinkedIn
Follow AstraZeneca on Facebook
Follow AstraZeneca on Instagram
