Posted Date: Apr 10 2025
Responsibilities:
- Prepare and manage all the meetings and documents related to the project (agenda, minutes, Team Site, et.)
- Initiate and manage change control
- Create qualification protocol in order to perform testing to confirm the design
- Conduct Failure Mode and Effect Analysis (FMEA)
- Developing the User Requirement Specifications (URS) and/or material specifications
- Based on the URS and the documentation received by the supplier, execute or oversee execution of Design Qualification (DQ).
- Create Design Summary Reports (DSR)
- According to the requirements that are still not met during the DQ, develop a Validation Master Plans (VMP) in order to meet all the requirements of the URS.
- According to the validation strategy developed in the VMP, write the IOQ protocol, conduct the test in the laboratory with the protocol and finalise the report based on the testing in the laboratory. Manage incidents that may occur during the laboratory testing.
- Compile and summarize the validation evidence in the Validation Summary Reports (VSR)
- Conduct Chemical Compatibility Risk Assessments (CRA) based on data from the supplier
- Perform Leachable Risk Assessments (LRA) covering extractible approaches
- Calculate Patient Exposure Scenarios (PES) based on the raw data from the supplier
- Manage the PO process, acquiring components from manufacturers.
- Ensure progress of the project in alignment with the implementation timeline
- Shipping of components from manufacturers to external laboratories, ensuring full GMP traceability, and completing the necessary GMP sending checklist.
- Provide weekly reporting on progress status, performances and issues to manager
Basic Qualifications:
- Advanced degree in chemistry, biology, chemical engineering or similar field of study.
- Knowledge of sterile drug product primary pack & devices, qualification process
- Project management skills and validation technical skills
- Experience with at least 10-16 year primary pack & devices qualification for a Pharmaceutical or Biopharmaceutical company.
- Ability to resolve complex technical issues by bringing creative solutions with the right quality framework
- Knowledge and understanding of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and ISO standards.
- Hands on mentality/approach and ability to work in the laboratory.
- Flexibility to face rapidly changing environment
- Ability to work in a matrix international organization.
- Proficiency in writing DSR, FMEA, URS, DQ, VMP, IOQ, VSR, qualification protocol, extractable protocols, biocompatibility reports, and leachable risk assessments and PES calculation.
- Written and oral fluency in English.
- Excellent communication and negotiation skills.
Preferred Qualifications:
- Strong interpersonal and communication skills and
- Demonstrated ability to work effectively across a diverse customer base
- Awareness of FDA, US Pharma and Good Manufacturing Practices (GMP) requirements related to packaging
- Ability to work effectively in a matrix organization across geographies and cultures
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 Trouble-shooting.
- 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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