Do you have expertise in, and passion for Quality Control & Manufacturing? Would you like to apply your expertise to impact an organisation that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
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.
It’s an exciting time for our team as we redefine the future, working towards our vision to be the leader in Cardiovascular, Renal, Metabolism, Respiratory and Immunology by 2025. Get to make your mark as you do something rewarding for patients, healthcare and our wider society. Jump in and be a part of it.
What you’ll do
Ensure compliance (cGMP, SHE and business procedure) is understood and maintained across QC area and Personnel, ensure that all work is carried out with regard to AstraZeneca and external regulatory policies and standards. Act as Qualified Person and Responsible Pharmacist for Quality Control of PT AstraZeneca Indonesia. Work as part of the Regional and Global QC network to share best practice and standardise QC ways of working. Optimizes performance outcomes of direct reports and ensures individuals understand the contribution they make. Coaches’ direct reports for enhanced performance, team and individual development on an ongoing basis. Maintain good communication to set clear direction and objectives and motivate and encourage all QC team. Maintain QC Operations, QC Release & Supply:
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.
Implement, monitor and update Quality Management System in QC lab.
Conduct QC activities in QC lab including Quality Inspection.
Ensure there is system in place for QC laboratories (packaging, chemical and microbiological lab), including operating instruction of instrument and QC operations.
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.
Conduct documentation system according to valid procedures and regular checking all of logbooks related to activities.
Prepare packaging material specification, bulk product specification and finished product specification.
Prepare analysis sheet for all material tested and ensure that QC analysis is performed based on valid and current procedure.
Review all analytical result.
Release/reject of incoming material (packaging material, bulk product and semi finish product) based on analytical result.
Manage retained sample according to approved procedure.
Ensure that environment monitoring execute timely based on approved schedule and procedure.
Ensure that monitoring of water and compressed air executed timely based on approved schedule and procedure.
Ensure there are procedures for analysis / inspection of non-inventory materials product contact.
Ensures appropriate analytical method validation has been conducted.
Perform qualification, maintenance status of the premises and equipment in QC area.
Support qualification and validation at Cikarang Site.
Report any deviation and OOS occurs in QC activities and investigate most probable root cause accordingly to prevent re-occurrence.
Raise Change Control proposal for any changes related to QC activities.
PR/PO creation include dealing with supplier after delivery (technical problem).
Maintain stock and availability of reagents, microbiology media and references standard.
Follows AZ’s financial policies, manages people resources to policy requirements and delivers the QC budget.
Continuous improvement & Strategic Project
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.
Strives to continuously improve the established ways of working.
Leads the implementation of LEAN and High Performing Lab that enable the group to achieve standard ways of working, efficiency, flexibility, and delivery.
Essential for the role
Bachelor’s degree in pharmacy and having apothecary degree.
Having experience in Pharmaceutical company in QA or QC activities at least 3 years preferably, in multinational company.
Familiar with quality system and implementation of GMP and QC standard.
Excellent communication skill
Good analytical skill and knowledge
Fluent in English
Familiar with Application of Lean ways of working in the QC environment.
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
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 https://www.linkedin.com/company/astrazeneca/mycompany/
Follow AstraZeneca on https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on https://www.instagram.com/astrazeneca/?hl=en
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.