Posted Date: Dec 16 2024
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
Ensure that analytical equipment is maintained and calibrated accurately and timely in accordance with site procedures, CAP and regulatory requirements.
Lead and/or participate in investigations arising from laboratory equipment/computer systems events and propose effective CAPA to minimize reoccurrence.
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.
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
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
Minimum Diploma in Science-related field with minimum 10 years of working experience
Minimum Degree in Science-related field with minimum 5 years of working experience
Extensive knowledge of GXP and laboratoray equipment calibration and maintenance
Extensive knowledge of quality, laboratory techniques and laboratory compliance
Good audit skills
Detailed knowledge of regulatory expectations/ATS/ICH requirements
Good investigating skills
Good communication skills
Good teamwork
People management skills
Good interpersonal skills
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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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