Quality Deputy Director

Hirehub Management Sdn. Bhd.; Pasir Gudang; On-site; MYR 96,000 - 120,000; Full time

Job summary

A company specializing in chemical raw materials is seeking a QA Manager in Pasir Gudang, Malaysia. The ideal candidate will have at least 7 years of experience in the pharmaceutical industry, including 5 years in a managerial role. Responsibilities include ensuring product quality, overseeing audits, and managing quality-related documents. Strong leadership and communication skills are essential, and proficiency in English is required.

Qualifications

• Minimum 7 years in the pharmaceutical industry, with at least 5 years in a QA Manager role.
• In-depth knowledge of ICH Q7 guidelines and FDA audit processes.
• Proficiency in written and verbal English; Mandarin is a plus.

Responsibilities

• Review and approve quality-related documents and conduct product quality reviews.
• Release or reject APIs and intermediates.
• Oversee internal audits and ensure maintenance of critical equipment.

Skills

Leadership

Quality Assurance

Communication

Audit Processes

Education

Bachelor's degree in Chemistry, Biology, Pharmacy or related field

Job description

Overview

Our client specializes in the research, development, production, and sales of daily chemical raw materials, including cosmetic active ingredients, raw materials, and synthetic perfumes. They operate two major production bases in Suqian City, Jiangsu Province, and Ma'anshan City, Anhui Province. The Ma'anshan City production base, through its subsidiary, was constructed according to GMP guidelines for APIs and has passed the FDA on-site audit.

Responsibilities

• Review and approve quality-related documents, and conduct product quality reviews.
• Release or reject APIs and intermediates, including raw materials, packaging, and labeling materials.
• Ensure investigation and resolution of critical deviations and quality complaints.
• Approve all specifications, master production instructions, and procedures impacting product quality, including those for contract manufacturers.
• Oversee internal audits, and ensure maintenance and calibration of critical equipment.
• Ensure proper material testing and reporting, including stability data to support retest/expiry dates and storage conditions.

Qualifications

• Bachelor's degree or higher in Chemistry, Biology, Pharmacy, or related field.
• Minimum 7 years in the pharmaceutical industry, with at least 5 years in a QA Manager role.
• In-depth knowledge of ICH Q7 guidelines, FDA, and EDQM audit processes.
• Proven experience leading quality organizations in a global matrix environment. Ability to make quality decisions in challenging situations.
• Proficiency in written and verbal English. Mandarin is a plus.
• Strong leadership, interpersonal, and communication skills.