Total 2 analyst job vacancies in D22 Jurong, Jurong Island, Tuas

Purpose

To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met. Ensure that all raw material, in-process and finished product testing and method transfer testing is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.

• Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures.
• Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath and etc.
• Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management.
• Review lot release data, identify testing discrepancies and participate in laboratory investigations.
• Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
• To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
• To carry out completion and review of GMP Documentation of data sheets or LIMS software.
• To carry out QC sample receipt, assay and release procedures.
• Support Audit preparation and any audit related activity.
• Reading and understanding the test procedure and the requirements per USP, JP and EP.
• Require to perform 12 hours shift work.

Qualification and experience

• Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree.
• More than 2 years relevant experience, preferably in the bio-pharmaceutical / Pharmaceutical industry.
• Good working knowledge of cGMP and regulatory requirements related to Quality is preferred.
• Problem-solving and troubleshooting skills.
• Highly motivated and independent.
• Possess good interpersonal and communication skills.
• Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance’s and industry standards for analytical development and characterization.

Job Overview:

This position is responsible for using analytical tools to collect, correlate and analyze data for use in (1) improving operational quality and productivity, (2) aid in the optimization of current business flow and (3) understand the impact of changes, improvements, or projects on operational performance.

Responsibilities:

• Use appropriate analytics platforms and analytical tools given specific analytics and reporting requirements.
• Utilize a range of statistical methods and analytics approaches to data.
• Conduct statistical modelling of data to derive patterns / solutions.
• Perform coding and configuration of software agents or programs based on a selected model or algorithm.
• Conduct tests on the actions taken and outcomes to assess effectiveness of the model.
• Elicit business requirements from operational management or other stakeholders using appropriate techniques.
• Explore relevant solutions or programs, from an existing repertoire, that can address business needs.
• Present solution options for consideration and explain how solutions will impact the business and address requirements.
• Select appropriate visualization techniques and information displays to convey data and findings.
• Organize the presentation of data to reflect trends and correlations in a visually compelling way.
• Incorporate appropriate elements to create informative and dynamic data displays.
• Develop basic dashboards and scorecards to display internal as well as external benchmark data.
• Incorporate interactive graphics, visuals, and technical features into the data presentation.
• Communicate limitations of data and interpretations of findings
• Conduct stakeholder mapping to identify facets and nature of relationships with and between stakeholders.
• Develop efficient processes to standardize and maintain data definitions, sources, and quality.
• Provide training and guidance to individuals who initiate the data analysis and dashboard reporting process.

Requirements

• Bachelor’s degree with 3 to 5 years of manufacturing process knowledge. Experience in the pharmaceutical industry is a plus.
• A self-starter, able to drive own initiatives and provide digital solution to drive operational excellence with business stakeholders.
• Experience in one or more scripting languages (e.g. Python, R, Shell) and skilled in writing performant SQL.
• Experience with Microsoft Power Platform (e.g. PowerBI, PowerApps and Power Automate).
• Working knowledge with SAP HANA is a plus.
• Strong analytical and data mining skills.
• Excellent Team Player