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Company | AstraZeneca |
Address | Cikarang Utara, Indonesia |
Employment type | FULL_TIME |
Salary | |
Category | Manufaktur Farmasi |
Expires | 2023-10-06 |
Posted at | 8 months ago |
QC Supervisor.
- Conduct QC activities in QC lab including Quality Inspection.
- Deliver QC operational performance. Ensure QC capacity and capability is in place to meet demand, ensuring all necessary testing is carried out. Prepare and monitor work schedule for QC analyst based on update QC timeline to consistently provide and supply high quality product.
- Support qualification and validation at Cikarang Site.
- Ensure there is system in place for QC laboratories (packaging, chemical and microbiological lab), including operating instruction of instrument and QC operations.
- Maintain stock and availability of reagents, microbiology media and references standard.
- Conduct documentation system according to valid procedures and regular checking all of logbooks related to activities.
- Ensure that monitoring of water and compressed air executed timely based on approved schedule and procedure.
- Raise Change Control proposal for any changes related to QC activities.
- Release/reject of incoming material (packaging material, bulk product and semi finish product) based on analytical result.
- Ensure there is a system in place for appropriate sampling, handling, and storage of reference sample of packaging and labelling materials and retained sample of finished product.
- Prepare packaging material specification, bulk product specification and finished product specification.
- Perform qualification, maintenance status of the premises and equipment in QC area.
- PR/PO creation include dealing with supplier after delivery (technical problem).
- Implement, monitor and update Quality Management System in QC lab.
- Ensure that environment monitoring execute timely based on approved schedule and procedure.
- Ensures appropriate analytical method validation has been conducted.
- Report any deviation and OOS occurs in QC activities and investigate most probable root cause accordingly to prevent re-occurrence.
- Follows AZ’s financial policies, manages people resources to policy requirements and delivers the QC budget.
- Prepare analysis sheet for all material tested and ensure that QC analysis is performed based on valid and current procedure.
- Review all analytical result.
- Ensure there are procedures for analysis / inspection of non-inventory materials product contact.
- Manage retained sample according to approved procedure.
- Coordinate Quality Strategic Project and support strategy deployment, alignment and the delivery (both QC and QA) and keep close connection with Site/Ops teams, regional network, and Lean function.
- Leads the implementation of LEAN and High Performing Lab that enable the group to achieve standard ways of working, efficiency, flexibility, and delivery.
- Strives to continuously improve the established ways of working.
- Good analytical skill and knowledge
- Excellent communication skill
- Familiar with quality system and implementation of GMP and QC standard.
- Having experience in Pharmaceutical company in QA or QC activities at least 3 years preferably, in multinational company.
- Bachelor’s degree in pharmacy and having apothecary degree.
- Familiar with Application of Lean ways of working in the QC environment.
- Computer literate
- Fluent in English
- 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.
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