A new biotechnology company located on the Penang Biotech Park is seeking suitably qualified and highly motivated candidates for the following position:

DIRECTOR OF QUALITY ASSURANCE AND REGULATORY AFFAIRS

Key Responsibilities

• Leadership, management and development of the quality system and implementation of the system within the company
• Establishment of the Quality Team to provide all of the QA / QC and Regulatory Affairs functions and support for internal and external clients
• Responsible for compliance with international regulatory standards
• Internal and external audits and the follow-up of corrective actions within a timely manner
• Liaison with international customers and all inter-company departments

Requirements

• Bachelor of Biotechnology or other related Life Sciences degree
• Minimum of 5 years management experience in QA / Regulatory Affairs in the biopharmaceutical industry
• A comprehensive understanding of international regulatory guidelines and regulations, including but not limited to EMEA and FDA
• Working experience of internal and external audits
• Qualified Person status preferable but not essential
• Excellent communication skills in English

Interested candidates please submit a detailed resume with contact number and a recent photograph to:

Director of Manufacturing
Alpha Biologics
PO Box 66
Pulau Tikus
10250 Penang
Malaysia

Or email: info@alphabiologics.com

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