Project Validation Coordinator
- University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
- At least 2 years experience in Aseptic Processing or Vaccine Production including knowledge of the Scale-Up principles, Quality Control tests, or in new Production Technologies.
- Experience in a matrix organization is an asset.
- Previous experience in PQ Validation is a plus.
- Fluent in French and good knowledge in English.
Please see "Basic Qualifications"
We are currently seeking a Project Validation Coordinator to join our Technical Research & Development (TRD) department. If interested, please read further.
GMP Manufacturing and Clinical Supply (GMP Mfg.) is critical to produce Clinical lots and robust product and process development and launch of novel vaccines. As the Project Validation Coordinator you will be responsible in supporting, in term of Validation, this role. You will work in collaboration with Quality Assurance, Production, Technical Services, Quality Control and Experts to lead the Validation.
- You will be responsible for the coordination of the Validation of projects in Primary or SecondaryTRD GMP Manufacturing on GSKBio site.
- You will ensure correct and state of the art Validation approaches, be responsible, with the coaching of your N+1 or other colleagues, to establish the Validation Plan and be accountable for all GMP decisions taken during the Validation of the Investment project starting with the Design Qualification step and ending with the establishment of the Validation Summary report.
- You will be responsible for writing, reviewing and approving validation documents (Risk Assessment, PQ Protocol, PQ Report,…).
- You will be responsible for coordination of PQ execution activities.
- You will be responsible for the implementation of the Validation guideline and SOP for the processes & equipment (Validation Life-Cycle process, Qualifications, Process Validation).
- You will be responsible for ensuring, during the design and validation steps, (until the end of consistency lots) for the facility project, writing, an independent review and first approval of validation documentation.
- You will participate to execute the writing of the facility submission files for the projects.
- You will be responsible to participate, for validation purposes, to inspections from external authorities (EMEA, FDA, WHO…) with the coaching of your hierarchical Manager (N+1).
- You will be responsible for the implementation of adequate validation strategy in compliance with the FDA, EMEA and International quality standards.
- You will be responsible for assuring inspection readiness – regarding Validation – by Corporate GSK requirements and RA authorities (FDA, EMEA, Canada) with the coaching of your N+1.
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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