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Job description :
Key Responsibilities:
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Oversee the Quality Control (QC) Laboratory and Quality Assurance function within the Quality Operations (QO) Department to ensure that appropriate systems are in place to meet or exceed site and regulatory requirements for the quality of products manufactured on site or by approved suppliers.
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Drive innovation in the QC Laboratory and the implementation of rapid analytical methodologies to improve laboratory procedures.
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Lead the Singapore QO Team, and manage the utilization of facilities and equipment to ensure that department objectives are met within budget guidelines.
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Ensure that product value streams and supply chain commitments are met via the use of agility / lean tools within the Quality function.
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Ensure the compliance of operations with the organization's Quality Standards, global and local regulatory requirements and interface with regulatory agencies as required.
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Monitor local and global regulatory trends to ensure that the Singapore site stays appropriately prepared for new initiatives or focus areas.
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Work closely with Production and key stakeholders to maintain consistent manufacturing policies and compliance with cGMP and other regulatory guidelines.
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Interact with QO Leaders from other sites to assess best practices and participate as required on global terms.
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Qualifications :
Requirements
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Bachelor’s Degree in Science, Pharmacy or related discipline with post-graduate qualifications in a technical or management related discipline.
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At least 10 years of experience in quality operations in the pharmaceutical industry; of which at least 5 years of demonstrated success in leading and developing professionals.
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Demonstrated record of successful interaction with the US FDA and other global regulatory agencies and auditing groups.
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Successful track record of continuous improvement, systems optimization, colleague development, and implementation of best practices in quality operations and/or manufacturing.
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Thorough knowledge and understanding of the technical and commercial aspects of pharmaceutical products.Highly developed influencing skills and proven ability to manage multiple, complex projects in an environment of change and continuous improvement.
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A leader with demonstrated ability to communicate and interact effectively with a range of personnel across functions, levels and sites.
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Well-developed maturity and emotional stability.
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