Requirements
\nJob Requirements:<\/p>\n
\tEducational Background: Bachelor\u2019s degree in chemical engineering, Organic Chemistry, Analytical Chemistry, or a related field.
\n\tTechnical Knowledge: Strong understanding of Chemical Engineering principles, Organic and Analytical Chemistry; proficiency in statistical analysis is advantageous.
\n\tIndustry Experience: Minimum of one year of experience in a pharmaceutical, cGMP-compliant, or chemical manufacturing environment. \u00a0Experience with manufacturing technology transfer projects is advantageous.
\n\tDocumentation & Data Analysis: Demonstrated ability to compile technical documentation, critically evaluate data, and ensure accuracy in regulatory submissions.
\n\tSoftware Proficiency: Strong proficiency in MS Office applications (Word, Excel, Outlook, Teams, Access, PowerPoint). Familiarity with Minitab and\/or EXTEDO is advantageous.<\/p>\n
Key Responsibilities:<\/p>\n
\tManufacturing & Cleaning Documentation: Compile and update manufacturing and cleaning instructions in compliance with internal procedures and regulatory standards
\n\tTechnology Transfer: Provide the appropriate support to ensure adherence to all established technology transfer timelines.
\n\tRisk Assessments: Evaluate the potential presence of elemental, genotoxic, and nitrosamine impurities following relevant regulatory guidelines.
\n\tProcess Qualification: Develop and finalize process qualification protocols and reports to maintain industry compliance.
\n\tProcess Evaluation & Improvement: Analyse and report on process performance, recommending enhancements where necessary.
\n\tAnnual Product Quality Reviews: Conduct annual reviews aligned with cGMP standards, identifying adverse trends and potential process improvements.
\n\tChange Implementation: Implement modifications related to testing and manufacturing processes in accordance with established company procedures.
\n\tRegulatory Documentation: Compile and update regulatory submissions, including Common Technical Documents for regulatory authorities.
\n\tData Management: Maintain and update relevant databases to ensure accurate capturing of Active Pharmaceutical Ingredient (API) data.<\/p>\n
Personal Attributes:<\/p>\n
\tStrong interpersonal, organisational, and systems implementation skills.
\n\tExceptional attention to detail and accuracy.
\n\tExcellent written and verbal communication skills in English, including strong report writing and document reviewing abilities.
\n\tAbility to manage multiple tasks concurrently.
\n\tSelf-motivated and results-driven.<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( ) or<\/p>\n
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