Analytical Support Officer (1 year contract)

Purpose

To ensure the analytical equipment and computer systems in the quality laboratories are installed, validated, calibrated and maintained according to relevant quality standards and procedures. To ensure the equipment and computer systems related procedures are created and updated according to the QMS standards and guidelines and static data configuration for laboratory related systems are managed in a timely manner and meet regulatory requirements.

Key Responsibilities Area

1. Ensure that analytical equipment is maintained and calibrated accurately and timely in accordance with site procedures, CAP and regulatory requirements.
2. Lead and/or participate in investigations arising from laboratory equipment/computer systems events and propose effective CAPA to minimize reoccurrence.
3. Perform periodic validation review of systems/laboratory equipment in a timely manner to ensure that the validation status is maintained and make recommendations for re-validation as required.
4. Lead or participate in laboratory equipment validation in accordance with site procedures and regulatory requirements, inclusive of writing, reviewing and approval of validation related documentations.
5. Perform accurate and thorough impact assessment on laboratory equipment, systems change control to ensure all impacted areas are adequately assessed and impacted documentation are updated in a timely manner.

Skills, Knowledge & Experience

1. Minimum Diploma in Science-related field with minimum 10 years of working experience.
2. Minimum Degree in Science-related field with minimum 5 years of working experience.
3. Extensive knowledge of GXP and laboratory equipment calibration and maintenance.
4. Extensive knowledge of quality, laboratory techniques and laboratory compliance.
5. Good audit skills.
6. Detailed knowledge of regulatory expectations/ATS/ICH requirements.
7. Good investigating skills.
8. Good communication skills.
9. Good teamwork.
10. People management skills.
11. Good interpersonal skills.