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 attitude, 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. Aligning work schedule for QA team to consistently provide and supply high quality product, ensuring the implementation of update Quality Management System applicable to QA operations. You will actively identify, develops, establishes, monitors, and maintains area Key Performance Indicators (KPI’s) as required. You’ll take any action needed to prevent situations that may jeopardize the patient safety, quality of the product or supply to market.
Quality oversight for manufacturing & supply activities:
- Provide experienced advice on Good Manufacturing Practice to Quality team and Operations and ensure compliance with the associated quality standards.
- Raise to Management (i.e Quality Manager and/or Site Lead) any discrepancies (potential or real) during daily operations.
- Participate in monthly production meeting.
- Manage and Control Deviation.
- provide Quality review and approval for minor deviation.
- conduct QA area investigations.
- support major and critical site investigations.
- Participate in problem solving or specific issues, to ensure GMP and regulatory compliance.
- 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.
- Manage and Control Change Management.
- provide Quality review and assessment.
- Manage and Control Site Risk management.
- Provide Quality review and assessment, including participate in the development and implementation of Quality Risk Assessments (QRA)
- Apply the first level of risk management by using analytical skills and experience to make decisions, develop solutions, or more complicated judgments, within general operating guidelines.
- Manage Supplier Selection, Supplier Qualification and supervising supplier Quality Performance
- Manage Supplier Deviation (material complaint)
- Work closely with Regional/Global External Sourcing & Logistic Quality (ESLQ) to maintain Quality Agreement with supplier
- Provide supporting managing supplier’s CAPA derived from AZ Audit
- Supervise and track all relevant QA CAPA report e.g. CAPA Investigation and CAPA Audit.
- Work as part of the Regional and Global Quality network to share best practice and standardize ways of working.
- Identify QA enhancement opportunities, and actively participate and coordinate with QA / QC Management the required activities to implement the opportunities.
- participates in company initiatives toward continuous improvement (New Products Introduction, GMP Improvement Programs, Kaizen events, GENBA walks, Lean) while providing guidance in the area knowledge and deliver timely results while contributing to business success.
- Perform review and assessment of update Quality Management System applicable to QA operations, and ensure the implementation/compliance
- Work as part of QA team and support in developing Self-Assessment and Internal Audit Program, coordinate the execution according to the plan, monitor the Audit Report and CAPA completion.
- Support the Audit Readiness Program and the execution
- Work as part of QA team in coordinating and tracking the Validation and Qualification activities at Cikarang Site, including the periodic review.
- Work as part of QA team in Quality investigation for Product Quality Complaint, review the trend and identify the improvement plan.
- Support in managing Recall Management (if any) including in executing periodic Mock Recall activities.
- Work as part of QA team and support in maintaining and delivering the GMP Training for Quality and Ops team
- Support development of Annual Product Review report and ensure the required information are provided on-time
- Coordinating the Stability Program/Plan with Global Stability team,
- Arrange the sampling plan and sample delivery with Cikarang Ops team
- Support Indonesia Marketing Company in: Product release for local market, Participate in QA-RA-Supply monthly meeting, Support MC in GMP/GDP activities align with AZ Policy, recent CPOB & CDOB and other applicable regulation, Support MC in 3rd party qualification and maintain the Quality Agreement
- 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 and GDP
- 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.
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, digitalisation 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.
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Date Posted 16-Nov-2022
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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