Job Description:
Role Purpose:
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Sustain the local Quality System and infrastructure for the Singapore Hub (secondary packaging).
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Carry out and provide quality oversight for the quality management to ensure compliance with applicable regulatory requirements and quality standards.
Main Accountabilities:
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Support Quality Systems and ensure effective use of Quality Tools for activities related to Good Manufacturing Practice and Good Distribution Practice.
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Act as the Key-User and Training Coordinator for training system. Ensure adequate training program is effective.
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Writes and co-ordinates the writing of SOPs and manages the administration of SOPs.
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Performs quality oversight of third party packager, distributor under area of responsibility as per compliance and business needs.
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Carry out Annual Product Reviews for Secondary Packaging.
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Carry out Batch Release for secondary packaging according to marketing authorizations and coordinate different activities with third party.
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Accountable for timely product releases avoiding backorders, while assuring product quality and compliance.
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Support Quality Review Board for Singapore Hub operations. Support in the issuance of monthly Quality status reports to monitor local GMP/GDP compliance.
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Investigate / assess deviations occurring during transport, packaging, storage, distribution of products.
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Support change control implementation.
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Carry out timely investigation of product complaints and ensure adequacy and timely implementation of CAPA.
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Coordinate potential recall activities, including mock recalls.
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Coordinate and perform self-inspection. Support inspection from regulatory authority and certified body.
Qualification and Experience Requirements:
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Educational requirements: relevant degree in pharmacy, chemistry, biology or health sciences.
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Preferred professional experience:
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Preferably 2-3 years’ experience in the pharmaceutical industry, in operational quality. Fresh-graduates are welcome to apply.
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Good Experience in Quality Assurance with basic knowledge in Good Manufacturing Practice and Good Distribution Practice.
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Good command in English and writing skill.
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8 months contract (February – September 2024)
Location:
Ferring Singapore
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