Purpose:
To manage QC equipment life cycle from qualification to decommissioning including calibration and maintenance plan follow up.

Responsibilities:

1. Manage new QC equipment qualification as per change control and validation processes (i.e. URS, System classification, Audit trail review assessment, DQ/IQ/OQ, PPC09)

2. Be author of SOPs/ protocols/ reports/ training materials

3. Manage decomissioning of QC equipment and follow disposal process

4. Maintain our QC asset listing up to date

5. Follow QC equipment routine lifecycle

6. Coordination of calibration and maintenance plan with user and external vendor/TS team

7. Coordination of equipment troubleshooting if occurence of failure/breakdow (i.e. Tag in/out equipment, Work order creation)

8. Liaise with external vendor for service quotation, escort vendor during service and approve invoice timely

9. Supports compliance activities:
- Performs regular L1 audits in QC
- Coordinates and supports all L2, L3 and L4 audits and the associated CAPAs

10. Lead and manage continuous improvement projects

11. Subject-matter-expert (SME)/ audit fronter for assigned topics

12. Manage ad-hoc tasks

13. Supports activities related to GPS (e.g. tiers, Gemba, DMAIC,5S, standard work etc) for continuous improvement.

14. Timely support for projects and new product introduction

Knowledge, Skills, and Experience:

Professional

• Fresh Science graduate with Degree in Chemistry, Biotechnology, Life Sciences or any relevant field

Technical

• Competent technical skills in project management
• Knowledge of cGLP & cGMP (advantage)
• Laboratory techniques (preferred)
• Provide technical support to QC operations (SOPs,protocols and report writing)
• Deviations, CAPA, continuous improvement
• Change control coordinator (Manage AL1/2/3 CC)
• SME/audit fronter for QC User Decision and related activities
• To be involved in the following tasks with guidance from N+1. Work involved will be of low complexity.

Business

• Effective report writing skills
• Planning and organization skills
• Able to work independently
• Team player
• Analytical skills with logical thinking
• Leadership skills (advantage)

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Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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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