- Singapore Singapore
Kerja Sepenuh Masa Chemist, Gaji tinggi SGD 5,200 di Biosensors International - Maukerja
Kongsi
Simpan
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
Summary
Responsible in the routine planning and scheduling in the daily operation in the chemistry and physical lab for all finished product lot release samples. Apply analytical skills and judgement to interpret test data by analysing basic scientific assessment.
Conduct laboratory investigation, write or review LIR, CAPA, RCA, NCIR, Risk Analysis and Risk assessment by hand-on experience and basic technical knowledge in testing activities for both chemistry and physical related testing.
Lead team to ensure the daily samples are analysed in accordance to existing SOP and standards and supervise in the cleanliness of the laboratory within the testing stations.
Roles and Responsibilities
Responsible in the daily planning and scheduling of chemistry and physical laboratory activities perform testing on finished products and other non-routine testing such as stability studies, validation studies, developmental prototype and clinical products
Maintain overall laboratory equipment and apparatus from master list to ensure they are performing for its intended usage and support the equipment and tooling backup program for smooth QC operations
To perform good troubleshooting skills to equipment and process issues and conduct in laboratory investigation on equipment failure documentation of non-compliance or out-of-spec situations
Support internal and external audit and follow up systematically in the post-audit findings by effectively implement the changes within the given period. Able to disseminate the changes using top-down approach for the team to be aware of the new information and practices.
Assist all laboratory related actions such as CAPA are effectively implemented within the given time period
Manage the test method pFMEA annual review program and maintain test procedure for up-to-date compliance.
Assess and develop the risk of all laboratory processes including non-conformance investigation report and perform a risk assessment to minimise the risk and severity with implemented controls.
Take the lead in planning, scheduling and the execution of all relevant validation assessment and ensure on time delivery of the laboratory efficiency/compliance improvement projects
Liaise and coordinate with external vendors in carrying out calibration / maintenance of lab equipment when necessary
Participate in new / existing analytical method transfer / validation and equipment qualification for the drug related testing and finished product release and ensure compliance toward Pharma GMP requirements
Write and develop protocol to support method transfer / validation, compendia method verification and equipment qualification when necessary
Oversee and analyse annual product quality trending review and ensure that the review is completed within the given timeline
Identify, monitor, source and solve for any laboratory gaps needed to be improved and implement in accordance to standards
Responsible in triggering laboratory personnel to learn and build up practical hands-on experience and technical knowledge on chemistry and / or physical testing in accordance to SOP to achieve full competency
Conduct, perform and co-ordinate with multiple requirements of new projects and improvement
Supervise and ensure an acceptable level of 5S housekeeping and LEAN lab concept in accordance to the Good Laboratory Practice
Revise and amend the standard operating procedures to reflect the current standards and practice are met
Assist in providing new quality standards and analytical test and implement it successfully once it has been approved
Plan, schedule and execute method validation, validation protocol, equipment qualification, record and studies during periodic reviews.
Involved and support the R&D activities and projects for new establishment, products, and changes
Manage laboratory investigation reports, analytical instrument qualification/calibration, test method validation, and maintain procedures to ensure up-to-date compliance.
Taking care of non-routine drug-related testing, ensure smooth lot release QC operations fulfilled QMP/GLP requirements and driving process/method improvement projects
Any other assignment in daily operations and project
Requirements
At least Degree in Science discipline (e.g. Chemistry, Pharmaceuticals, Chemical Process)
Preferable with at least 3-5 years relevance experience in a laboratory environment
Ability to operate and technically explain LC, GC, and UV-Vis Spectrophotometer independently.
Good knowledge in GLP and analytical test methods.
Preferable with experience on functionality related testing and / or QA/QC operations
Strong Interpersonal and communication skill and possess positive attribute
Ability to adopt to the fast-pace and high pressure laboratory environment
Knowledgeable of applicable cGMP’S, MDD (93/94/EEC), ISO 9001, EN 46001 and ISO 13485
Strong knowledge of chemistry and related fields
Strong in Microsoft Office Applications such as Excel, Word and PowerPoint
Good analytical and troubleshooting skills.
Good communication skills to communicate with all project teams from Asian area
For more than 25 years, the Biosensors International Group (“Biosensors”) has been developing and marketing critical care catheter systems and related devices used during heart surgery and intensive care treatment.
Continually striving to be at the forefront of product innovation, with a focus on improving patient outcomes today, we are driving the development of tomorrow’s next generation medical technology.
In the year 2000 we entered the interventional cardiology market and immediately became the first cardiology company to develop and patent their own proprietary limus agent, Biolimus A9 (BA9), a highly lipophilic1 anti-restenotic drug designed for cardiovascular stent technologies.
We were also the first stent company to develop and launch a biodegradable polymer stent with only the abluminal side coated with polymer and drug to reduce systemic exposure.
Over the last two-decades Biosensors has become one of the largest manufacturers and suppliers of cardiovascular stents globally.
Responsible in the routine planning and scheduling in the daily operation in the chemistry and physical lab for all finished product lot release samples. Apply analytical skills and judgement to interpret test data by analysing basic scientific assessment.
Conduct laboratory investigation, write or review LIR, CAPA, RCA, NCIR, Risk Analysis and Risk assessment by hand-on experience and basic technical knowledge in testing activities for both chemistry and physical related testing.
Lead team to ensure the daily samples are analysed in accordance to existing SOP and standards and supervise in the cleanliness of the laboratory within the testing stations.
Roles and Responsibilities
Responsible in the daily planning and scheduling of chemistry and physical laboratory activities perform testing on finished products and other non-routine testing such as stability studies, validation studies, developmental prototype and clinical products
Maintain overall laboratory equipment and apparatus from master list to ensure they are performing for its intended usage and support the equipment and tooling backup program for smooth QC operations
To perform good troubleshooting skills to equipment and process issues and conduct in laboratory investigation on equipment failure documentation of non-compliance or out-of-spec situations
Support internal and external audit and follow up systematically in the post-audit findings by effectively implement the changes within the given period. Able to disseminate the changes using top-down approach for the team to be aware of the new information and practices.
Assist all laboratory related actions such as CAPA are effectively implemented within the given time period
Manage the test method pFMEA annual review program and maintain test procedure for up-to-date compliance.
Assess and develop the risk of all laboratory processes including non-conformance investigation report and perform a risk assessment to minimise the risk and severity with implemented controls.
Take the lead in planning, scheduling and the execution of all relevant validation assessment and ensure on time delivery of the laboratory efficiency/compliance improvement projects
Liaise and coordinate with external vendors in carrying out calibration / maintenance of lab equipment when necessary
Participate in new / existing analytical method transfer / validation and equipment qualification for the drug related testing and finished product release and ensure compliance toward Pharma GMP requirements
Write and develop protocol to support method transfer / validation, compendia method verification and equipment qualification when necessary
Oversee and analyse annual product quality trending review and ensure that the review is completed within the given timeline
Identify, monitor, source and solve for any laboratory gaps needed to be improved and implement in accordance to standards
Responsible in triggering laboratory personnel to learn and build up practical hands-on experience and technical knowledge on chemistry and / or physical testing in accordance to SOP to achieve full competency
Conduct, perform and co-ordinate with multiple requirements of new projects and improvement
Supervise and ensure an acceptable level of 5S housekeeping and LEAN lab concept in accordance to the Good Laboratory Practice
Revise and amend the standard operating procedures to reflect the current standards and practice are met
Assist in providing new quality standards and analytical test and implement it successfully once it has been approved
Plan, schedule and execute method validation, validation protocol, equipment qualification, record and studies during periodic reviews.
Involved and support the R&D activities and projects for new establishment, products, and changes
Manage laboratory investigation reports, analytical instrument qualification/calibration, test method validation, and maintain procedures to ensure up-to-date compliance.
Taking care of non-routine drug-related testing, ensure smooth lot release QC operations fulfilled QMP/GLP requirements and driving process/method improvement projects
Any other assignment in daily operations and project
Requirements
At least Degree in Science discipline (e.g. Chemistry, Pharmaceuticals, Chemical Process)
Preferable with at least 3-5 years relevance experience in a laboratory environment
Ability to operate and technically explain LC, GC, and UV-Vis Spectrophotometer independently.
Good knowledge in GLP and analytical test methods.
Preferable with experience on functionality related testing and / or QA/QC operations
Strong Interpersonal and communication skill and possess positive attribute
Ability to adopt to the fast-pace and high pressure laboratory environment
Knowledgeable of applicable cGMP’S, MDD (93/94/EEC), ISO 9001, EN 46001 and ISO 13485
Strong knowledge of chemistry and related fields
Strong in Microsoft Office Applications such as Excel, Word and PowerPoint
Good analytical and troubleshooting skills.
Good communication skills to communicate with all project teams from Asian area
For more than 25 years, the Biosensors International Group (“Biosensors”) has been developing and marketing critical care catheter systems and related devices used during heart surgery and intensive care treatment.
Continually striving to be at the forefront of product innovation, with a focus on improving patient outcomes today, we are driving the development of tomorrow’s next generation medical technology.
In the year 2000 we entered the interventional cardiology market and immediately became the first cardiology company to develop and patent their own proprietary limus agent, Biolimus A9 (BA9), a highly lipophilic1 anti-restenotic drug designed for cardiovascular stent technologies.
We were also the first stent company to develop and launch a biodegradable polymer stent with only the abluminal side coated with polymer and drug to reduce systemic exposure.
Over the last two-decades Biosensors has become one of the largest manufacturers and suppliers of cardiovascular stents globally.
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