Posted Date: Apr 10 2025
Responsibilities:
- The job owner will work with external laboratories for outsourced Extractables and Leachables analyses i.e. set up adequate Extractables & Leachables study protocols aligned with GSK E&L requirements, coordinate the samples collection and shipment to the laboratory, received the study test results report and write the GSK final study reports applying GMP and GDP practices including respect of Data Integrity rules.
- The job owner will be part of core team of E&L strategic program execution
Basic Qualifications:
- Advanced degree in chemistry, biology, chemical engineering or similar field of study.
- At least 1-5 years of experience in pharmaceutical or biopharmaceutical MSAT or a related field. A working experience of at least 1 year in the field of E&L validation is required.
- Risk Management
- Regulatory knowledge related to E&L expertise
- Strong technical writing skills
- Benchmarking skills
- Multicultural mindset skills
- Enable and drive changes, influence skills
- Teamwork ability skills
- Problem solving skills
- Prioritization skills
- Execution & coordination skills in validation.
Preferred Qualifications:
- Competent in use of templates and forms
- Strong skills in Microsoft Excel, Microsoft Office, and PowerPoint
- Good understanding of good manufacturing practices
- Ability to understand technical processes
- Excellent communication skills
- Ability to train and coach others.
Scope:
The GSK MSAT team is responsible for ensuring that products are produced safely,
efficiently, and to the highest quality standards. Here are some key activities carried out by the MSAT team:
Process Optimization and Troubleshooting.
- Technology Transfer.
- Process Validation.
- Continuous Improvement.
- Technical Support.
- Regulatory Compliance.
- Data Analysis and Reporting.
- Training and Development.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
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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