Chemist

**Responsibilities**:

- Responsible of non-routine testing such as BA9 incoming receiving, Primary BA9 standard qualification, stability studies, validation studies, developmental prototype and clinical, the up-to-date compliance of test method toward the reference standard as well as new product/changes implementation and method transfer activities.
- Maintain overall laboratory equipment and apparatus from master list to ensure they are performing for its intended usage and within the calibration validity.
- To be able to perform good troubleshooting skills to equipment and process issues
- Conduct in laboratory investigation on equipment failure documentation of non-compliance or out-of-spec situations by using 5M 1E, fishbone or 5W 1H to identify the root cause
- Assess and develop the risk of all laboratory processes/test methods and take care of the annual review program, and non-conformance investigation report and perform a risk assessment to minimise the risk and severity with implemented controls.
- Assist all laboratory related actions such as CAPA are effectively implemented within the given time period
- To support in providing laboratory solution to continually improve and lean the laboratory process, minimise cost and reduce laboratory error caused by human factor
- To identify and execute laboratory efficiency improvement
- To approve test results of all testing data on behalf of the lot release QC manager during his / her absence.
- Participate in new / existing analytical method transfer / validation and equipment qualification when needed
- 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, the lab investigation trending review and ensure that the review is completed within the given timeline. Then initiate and execute projects for the possible efficiency or quality improvement opportunities
- 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 in accordance to SOP to achieve full competency
- Conduct, perform and co-ordinate with multiple requirements of new projects and improvement to achieve annual key performance given by direct supervisor
- Supervise and ensure an acceptable level of 5S housekeeping in accordance to the GLP (Good Laboratory Practice) as well as fulfilling the requirements for the safety and EMS (Environmental Management System) aspects.
- 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, record and studies during periodic reviews
- Other adhoc laboratory matters and duties assigned by direct supervisor

**Job Requirements**
- 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 liaise with English and Mandarin counterparts
- Strong in Microsoft Office Applications such as Excel, Word and PowerPoint
- Possess ability to operate and technically explain LC, GC, and UV-Vis Spectrophotometer independently.
- Good knowledge in GLP and analytical test methods.
- Strong Interpersonal and communication skill and possess positive attribute
- Ability to adopt to the fast-pace and high pressure laboratory environment
- Able to make decision on behalf of manager absence and lead the team
- Knowledgeable of applicable cGMP’S, FDA, MDD (93/94/EEC), ISO 9001, EN 46001 and ISO 13485
- Strong knowledge of chemistry and related fields
- Good analytical and troubleshooting skills.