AstraZeneca Pharmaceuticals LP Quality Assurance cum Regulatory Affairs Executive in Petaling Jaya, Malaysia
AstraZeneca is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in important areas of healthcare: gastrointestinal, cardiovascular, diabetes, respiratory, cancer and infection.
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.
As a Quality Assurance (QA) cum Regulatory Affairs (RA) Executive, you will safeguard the quality and compliance of AstraZeneca’s products and build a strong relationship with our customers to make a positive impact on changing patients’ lives.
Main Duties and Responsibilities:
Your job responsibilities will be, but not limited to:
· Developing and implementing Quality Management System (QMS) and other QA processes within AZ, aligned with local and global requirements to maintain our license to operate. · Management of major quality incidents and product recalls, product security matters, and relevant QA matters. · Ensuring compliance to internal standards and processes via effective training, assessments and audits. · Performing review and approval for release of locally reworked batches and assessment of stocks, as necessary.· Implement regulatory strategies and processes to gain rapid and high quality approvals and ensure regulatory compliance, in order to achieve company’s business objectives and ensure existing product licenses are maintained to high standards.
Essential Requirements:· Degree in Pharmacy or Degree in Life Sciences· Preferably, 2-3 years’ work experience in QA/RA positions in pharmaceutical companies · Familiar with local regulatory & quality requirements & local Health Authority personnel· Experience in facilitating issue management (e.g. product recalls, product security issues)Desirable Requirements:- Prior industry experience in QA is preferred- Ability to adapt quickly and flexibility in a fast-paced learning environment
We offer attractive remuneration & benefit package and excellent opportunity for your career development.
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.