Boston Scientific Analytical Chemist 

Malaysia, Penang 

361456746

Purpose Statement:

The purpose of the Chemist role is to conduct analytical testing on commercial, stability and non-routine samples, in addition to participate in the test method development, validation and technical transfers as required. They are responsible for ensuring that all testing is carried out in accordance with cGMP.

Key Responsibilities:

• Primary Commitment to patient safety and product Quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment calibration and qualification as required.
• Review of all laboratory Quality Systems to ensure compliance to cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
• Review and approval of Laboratory results and documentation, as required the trending and charting of data.
• Perform and assist with additional duties as may be directed by the Lab Management.
• Proficient in the use various software application utilized in the laboratory. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
• Create, review and approve change requests as required.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory spend and approval of vendor invoices.
• Management of laboratory inventory and supplies and ordering of same.
• Manage laboratory training process and maintenance to training status.
• Provide analytical support to process validations.
• Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required.
• Coordinate method transfer activities among inter-sites.
• Coordinate Preventive Maintenance and Calibration activities for equipment.
• Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
• Prepare analytical protocol for test-method related studies and test activities as method transfer, validation, etc.
• Manage/handle lifecycle management of an equipment, i.e., Procurement, Commissioning, Qualification Maintenance, Calibration and Retirement of the equipment and software.
• Handle analytical equipment and software qualification activity as per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems.
• Subject Matter Expert (SME) for Equipment troubleshoot and ensure the availability of contingent equipment in the event of equipment breakdown and provide equipment user training to the lab personnel.
• Routinely monitor the Equipment PM and Calibration due dates - ensure no event of Calibration/PM overdue.
• Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival).
• Routinely inspect the Equipment for proper use and care by the analyst.
• Initiate and own NCEP/CAPA as per required.

Requirements:

• Candidate must possess at least a Bachelor's Degree in Chemistry, Analytical Chemistry, Applied Science or Life Science.
• At least 2 years of experience in Analytical Lab set-up, Analytical equipment qualification and Chemical Analysis.
• Required skill(s): FTIR, HPLC, GCMS, GCFID Analytical Analysis and equipment qualifications.
• Experience in LIMS set-up and empower software is preferable.
• Knowledge of GMP, GLP, ISO13485 will be added value.
• Required language(s): English