Quality Assurance & Control (Manufacturing, Transport & Logistics)
Review and approve all appropriate quality-related documents; performing product quality reviews.
Releasing or rejecting all APIs; releasing or rejecting intermediates for use outside the control of the manufacturing company.
Establishing a system to release or reject raw materials, intermediates, packaging, and labeling materials.
Ensuring that critical deviations and quality-related complaints are investigated and resolved.
Approving all specifications and master production instructions; all procedures impacting the quality of intermediates or APIs; intermediate and API contract manufacturers, changes that potentially impact intermediate or API quality.
Ensuring that internal audits (self-inspections) are performed; effective systems are used for maintaining and calibrating critical equipment.
Reviewing and approving validation protocols and reports.
Ensuring that materials are appropriately tested and the results are reported; stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates where appropriate.
Job Qualifications
Possess at least a bachelor's degree and above in chemistry, biology, pharmacy, or equivalent, with 7 years' experience in a pharmaceutical factory, and at least 5 years as a QA Manager; with a thorough knowledge of chemistry, pharmacy, and/or biotechnology.
Familiar with ICH Q7 guidelines and have accepted FDA, EDQM audit experience.
Profound experience leading sophisticated quality organizations in a diverse global matrix environment; ability to speak up and to take quality decisions during challenging situations.
Proficiency in both written and verbal English language; Mandarin speaking skills would be an added advantage.
Strong leadership skills with excellent interpersonal and communication abilities.#J-18808-Ljbffr