Specialist QA Investigational Medicinal Product
il y a 1 semaine
As a, we empower you to be yourself, share ideas and work collaboratively
_ Specialist QA Investigational Medicinal Product (IMPQ)_:
Job purpose:
- You act with colleagues of CM&S Quality and our partners to ensure the continuous supply of clinical vaccines in line with GSK business objectives to meet customer needs.
- In the respect of Quality, Safety, GSK standards and cGMP regulations, you develop, assure, and maintain the quality of the product and processes
- Standard procedures
- Quality audits/review
- Key Performance Indicators (KPIs)
- Step quality decision
- You perform QA oversight for GMP production and R&D Analytics. Part of a team as QA for introduction of new product into our facilities (Multiple Building) and GMP production.
Validation & technical services for this role.
In this role you will
- Quality management_
- Take the full Quality Assurance responsibility for one or multiple operational activities related to development, investigational vaccines manufactured, and GIO support in the QA IMPQ department.
The responsibility covers aspects listed below:
- Validation
- Technical services
- Ensure QA oversight of the GMP documentation
- Approve master production records and procedures for production
- Develop strong partnership with business partner to ensure that CPP and CQA are adequately integrated in the operational procedures or master batch record and in line with PVDS requirements
- Ensure all GMP productions are in line with product development evaluations, effective procedures and regulatory requirements
- Ensure all equipment's, QC method and processes are adequately calibrated, qualified and validated (regarding development phase)
- Ensure all assay validation and lifecycle management documentation in ARD GMP are in line with applicable internal and regulatory requirement
- Ensure QA oversight for deviations, complaints, change controls, OOS investigation, CAPA in his field of activities.
- Represent QA in all operational meetings related to the area of responsibility (staff meetings, deviation, CAPA, change control followup meetings, ).
- Assure regulatory inspection readiness and provide QA expertise to act as a key spokesperson during external regulatory inspection. Ensures CAPA followup.
- Safety / Quality_
- Put in place the necessary actions to ensure the safety of staff
- Identify improvements in terms of EHS
- Respect and ensure the wearing of personal protective equipment (EPI)
- Continuous Improvement_
- Train production and QA teams to new procedures or GMP refresh.
- Provide quality environment and leadership for change initiatives in the area of expertise which contribute to the overall effective improvement of GSK Vaccines Manufacturing and Supply.
- Contribute to the process robustness through the redaction/review of data or document (eg: trend analysis, Risk assessment, SOP, guidance, etc )
- Active Team Member _
- Propose and follow annual objectives for the team. Prioritize and organize own work to deliver to shortterm deadlines. Measure the effective performance.
- Ensure Quality Oversights on the shopfloor (50%) to transfer practical information, knowledge and improvement tracks.
- Contribute to the cohesion and group dynamics and transfer all relevant technical knowledge or relevant organizational information to the team
_ This job opportunity is a permanent contract __not_
_ opened for relocation. _
_Why you? _
- Qualifications & Skills:_
- Sciences degree: Master or Bachelor with equivalent experience
- Minimum 5 years' experience in Quality Operations in a GMP environment or QA R&D
- Equipment validation & maintenance, qualification with the pharmaceutical / biopharmaceutical industry
- French is mandatory (daily interactions), good English level (documentation, inspections, etc.)
- Preferred Qualifications & Skills:_
- Agility in decision making and reflection
- Autonomy et polyvalence
- Capacity to work in project mode and change agility
- Curiosity, eagerness to learn
- Problem solving and continuous improvement approach
- _Li
- GSK_
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
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.
Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of dise-
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