Boston Scientific Chemist - P1 

Malaysia, Penang 

292088769

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.

Job 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 analysis of raw material, in-process, finished product, Stability and process validation samples.
• 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 qualification per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems as required.
• Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival).
• Review of all laboratory Quality Systems to ensure compliance with cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Perform and assist with additional duties as may be directed by the Lab Management.
• Proficient in the use of various software application utilized in the laboratory, i.e LIMS, Waters Empower. 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 inventory and supplies and ordering of same.
• Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required.
• Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
• Initiate and own NCEP/CAPA as per required.
• Conduct initial reviews of laboratory data packs to ensure accuracy and completeness.

Job Requirements:

• Candidate must possess at least a Bachelor's Degree in Chemistry, Analytical Chemistry, Applied Science or Life Science.
• At least 2-5 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