AstraZeneca is a leading global biopharmaceutical company. We believe the best way we can help patients is to focus on breakthrough science to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.

At AstraZeneca Malaysia, we aim to be the fastest growing pharmaceutical company in Malaysia in the therapeutic areas of cardiovascular, diabetes, oncology and respiratory. Through this ambition, we are confident that we can transform the lives of Malaysian patients by ensuring that they have access to life-changing medicines. Working here means being a member of our family in making a difference in delivering better health for Malaysian patients.

Job Description

As a Quality Assurance Manager, you are a qualified professional with strong subject knowledge, both in depth and breadth with experience from a number of different areas of quality.

Key Responsibilities

• Ensure effective operational implementation of the QMS across all GxP areas with appropriate levels of resource to complete GMP/GDP activities appropriately.
• Ensure appropriate functional QMS elements are in place and described the local Quality Manual.
• Provide information on the GxP license to operate status of the Country.
• Ensure GxP compliance is visible to CP and Area by active liaison with GxP Quality Leads.
• Report GxP compliance status to CP & MC Leadership Team through the MC Management Review meeting.
• Provide and coordinate training and coaching in the related GxP area for the MC QMS.
• Identify areas of compliance risk and follow-up of any issues.
• Ensure GxP self-assessments in the corresponding GxP area.
• Manage product supply, distribution activities and handle Post Marketing Surveillance processes.
• Monitor important metrics in the relevant GxP area and proposing remedial and improvement actions
• Monitor internal and external factors such as emerging regulation or shifts in regulatory enforcement
• Identify trends and communicate identified risks. Liaise with regulatory bodies and resolve issues within area of responsibility.
• Take end to end ownership to resolve quality issues and coordinate with key partners to reach a resolution.

Requirements

• You have a Bachelor’s Degree in Science or any related field.
• Demonstrated ability in a QA and/or QMS managerial role.
• Preferably with experience in the pharmaceutical industry, FMCG industry may be considered.
• Experience in manufacturing would be an advantage.
• Well versed in QMS and NPRA’s GDP Guidelines.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

Date Posted

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.