Develop marketing, sales and promotional tools and ensure compliance to company guidelines and relevant legislation in order to achieve marketing and sales goals.
Manage the elements of the product and marketing mix to achieve the sales and profit objectives of the portfolio.
Conduct field visits with Sales Representatives or Area Sales Managers to collect feedback on current campaigns and market conditions/needs.
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Develop cleaning validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion
Manage qualification/validation execution and lead the validation deviation investigations encountered during qualification/validation
Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities
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Develop, review and/or approve validation lifecycle documents and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
Take lead and review project design documents (P&IDs, PFDs, URS etc.)
Define user requirements and create SOPs or documentation related to the validation activities
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Support other technical changes and duties as required About You
Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science. At least 4 to 6 years qualification/validation experience. Cleaning validation experiences in Biologics and/API process.
Based in Tuas Duration of Contract: starting from mid-Jul 2024, 09 months. Subject to extension based on performance and business needs.
Support equipment/system qualification and cleaning validation
Develop cleaning validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion
Manage qualification/validation execution and lead the validation deviation investigations encountered during qualification/validation
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Effectively facilitate cross-functional discussions associated with investigation’s cause, remediation and impact analysis.
Manage the remediation as owner (if necessary), working collaboratively across several functions to achieve timely closure.
Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
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Responsible for providing CSV documents and protocols, performing execution for automated equipment and/or control systems, and closure of executed protocols.
Provide guidance on test case execution and exception handling and system SOPs.
Work with QA and program manager to ensure the project team understands GMP and validation requirements.
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• To perform Receipt, Pick and Pack, Returns, Rejects and Destruction and Secondary Packaging operational processes for pharmaceutical products for clinical trials
All qualified applicants, please send in your resume
Support Internal audit, audit CAPAs follow-up (discussion of response) and management of open audit CAPAs (if required)
Support external inspections (logistics and backroom support)
Support for other areas (Quality risk management, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents
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Support day to day production activities and record data according to Electronic Batch Record (EBR) in compliance with GMP, Environmental, Health and Safety guidelines.
Perform equipment and process monitoring
Able to communicate with Supervisor/supporting functions for any safety, quality, and process irregularities
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Support external inspections (logistics and backroom support)
Support for other areas (Quality risk management, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents
Event organization and/or other administrative tasks as assigned by Manager/Delegate.
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Able to lead project for Method validation/verification/transfer to introduce new/remediated QC methods for testing existing and new products independently
• Subject matter expert in method validation, verification and transfer; covering wide arrays of methods and complex techniques
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