Job Description

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Main Accountabilities:

• Support Quality Systems and ensure effective use of Quality Tools for activities related to Good Manufacturing Practice and Good Distribution Practice.
• Act as the Key-User and Training Coordinator for training system. Ensure adequate training program is effective.
• Writes and co-ordinates the writing of SOPs and manages the administration of SOPs.
• Performs quality oversight of third party packager, distributor under area of responsibility as per compliance and business needs.
• Carry out Annual Product Reviews for Secondary Packaging.
• Carry out Batch Release for secondary packaging according to marketing authorizations and coordinate different activities with third party.
• Accountable for timely product releases avoiding backorders, while assuring product quality and compliance.
• Support Quality Review Board for Singapore Hub operations. Support in the issuance of monthly Quality status reports to monitor local GMP/GDP compliance.
• Investigate / assess deviations occurring during transport, packaging, storage, distribution of products.
• Support change control implementation.
• Carry out timely investigation of product complaints and ensure adequacy and timely implementation of CAPA.
• Coordinate potential recall activities, including mock recalls.
• Coordinate and perform self-inspection. Support inspection from regulatory authority and certified body.

Qualification and Experience Requirements:

• Educational requirements: relevant degree in pharmacy, chemistry, biology or health sciences.
• Preferred professional experience:
• Good command in English and writing skill.
• Preferably 2-3 years’ experience in the pharmaceutical industry, in operational quality. Fresh-graduates are welcome to apply.
• Good Experience in Quality Assurance with basic knowledge in Good Manufacturing Practice and Good Distribution Practice.
• Good command in English and writing skill
• Temporary position for 6 months contract

Location: Ferring Singapore