Chemist

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 projects

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