An organisation is seeking aDeputy Director | Quality .
Job Descriptions
Review and approve all appropriate quality-related documents; perform product quality reviews.
Release or reject all APIs and intermediates for use outside the control of the manufacturing company.
Establish a system to release or reject raw materials, intermediates, packaging, and labelling materials.
Ensure that critical deviations and quality-related complaints are investigated and resolved.
Approve all specifications and master production instructions; all procedures impacting the quality of intermediates or APIs; intermediate and API contract manufacturers, and changes that potentially impact intermediate or API quality.
Ensure that internal audits (self-inspections) are performed; effective systems are used for maintaining and calibrating critical equipment.
Review and approve validation protocols and reports.
Ensure 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 pharmaceutical factory, including at least 5 years as a Manufacturing and QA Manager; with thorough knowledge in 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, with the ability to speak up and make Quality decisions during challenging situations.
Proficiency in both written and verbal English; Mandarin speaking skills would be an added advantage.
Strong leadership skills with excellent interpersonal and communication abilities.#J-18808-Ljbffr