Product Technical Complaints
il y a 1 semaine
Site Name:
Belgium-Wavre
Posted Date:
Jan
_ QA Specialist - Product technical Complaints_:
In this role you will
- Ensure complaints are recorded, investigated adequately and answered in a timely manner for GSK vaccines worldwide (More than 120 markets).
- Analyze complaint trends and manage complaints in such a manner to prevent recurrence of complaints, major incidents and recalls from the market.
- Manage technical signals seen on certain batches in accordance with procedures in place
- Maintain continuous interactions with the Pharmacovigilance department in order to ensure appropriate safety review of potential quality issues
- Participate actively in taskforces related to Complaints
- Respond to external (GSK commercial units) and internal (Manufacturing sites, Safety, etc.) clients' needs through explanation and clarification of issues and reporting (per building, site, product, country, topic )
- Participate to the Management of serious product incidents on vaccines, which may lead to product recalls and communications to authorities, by being the Secretary of the Product Incident Review Committee (PIRC). PIRC is a crossfunctional and multidisciplinary team involving representatives (Directors, VPs, experts) from different departments as Production, Quality & QC, Safety, Medical, Regulatory, Legal and Communications. The mission of the PIRC is to evaluate and decide if a batch must be recalled. Liaise With GSK Corporate to ensure the Product Incident Management Process is respected.
- Coordinate vaccines recalls with stakeholders at sites and with GSK commercial units at country levels (= Local Operating Companies)
- Contribute to the continuous improvement of the Complaints Management and Product Incident Review Comittee Systems.
_ This job opportunity is a permanent contract __not_
_ opened for relocation. _
_Why you? _
- Qualifications & Skills:_
- You have a master's degree, preferably with a scientist orientation
- You have minimum 2 years of experience
- You are fluent in French and English
- You have experience with change and stakeholder management
- You have strong abilities to communicate to all levels of the organization, both within local operations and with Global functions
- You are proactive and autonomous
- Ability to engage people from different areas of expertise.
- Ability to work effectively in a highly matrixed organisation across geographies and cultures.
- Ability to work in a regulated environment of pharma / biopharma / vaccines industry.
- Ability to communicate complex information both orally and in writing.
- Preferred Qualifications & Skills: _
- Knowledge of GMP regulated environment, Pharmacopeia is an advantage
- Proactive and autonomous
- Resilient, can work under some pressure
- Flexible, open to change
- Organized, Structured, Rigorous, Reliable
_ Why GSK?_
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 organization 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 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.Find out more:
Annual Report 2021
Li-GSK
GSKTechTalent
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 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and In-
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