Project Manager
Aussicht: 140
Update Tag: 26-11-2025
Ort: Wavre Walloon Brabant
Kategorie: Qualitätssicherung / Qualitätskontrolle Produktion / Betrieb Hohe Technologie
Industrie: Pharmaceutical Manufacturing
Jobtyp: Full-time
Jobinhalt
Site Name: Belgium-WavrePosted Date: Oct 25 2021
We are looking to recruit a Project Manager, for the MPU (Manufacturing Production Unit) Formulation.
Your Responsibilities
- You are responsible for site continuous validation activities and RPC coordination: establish and execute CVP (Continuous Validation Plan) and coordinate RPC (from VMP to QSR) for all the streams, i.e. Primary and secondary equipment including Computerized System Validation (Process control & automation) such as media fill, media form, SIP, CIP, autoclaves load and utilities (EDI, EPI, EUF, VP, ACP, N2)
- Through your team, you deliver validation services including IQ/OQ and PQ support (writing and review/approval of protocols), check-list review, update core files, deviation and out of specification investigation,…
- You manage budget: forecast, cost tracking,…
- You develop validation expertise within your team in order to be recognized as single point of contact for site validation activities and expertise.
- You manage validation support (in the field) team activities: sampling, BIs management, probes and indicators positioning, data encoding in SAP,..
- You allocate local support resources to major projects
- You are responsible for ensuring inspection readiness regarding validation during internal GSK audits and external authority’s inspections (EMEA, FDA, WHO…) and to assure follow-up of site related validation commitments.
- For RPC and Continuous validation, you present files to authorities during inspection
- You are responsible for coordinating the interaction related to validation between Local Validation and Global Validation as well as Global QA, RA or IT and steams (continuous validation plan, deviations review, sites quality council…)
- You participate in the evaluation of new standards: evaluate impact on local activities and integrate best practices.
- For continuous validation activities, you lead the Local Validation coordination meeting
- You act as expert to help and train customer (streams) in validation activities. You are responsible for coaching newcomers in the validation team and trainees from GSK Bio sites in the GMP and validation context in order to develop skills and competencies and to implement best practices.
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- At least 8 to 10 years’ experience in aseptic processing or vaccine production.
- Fluent in French and good level of English (written and oral)
- Expertise in validation, good knowledge of international standards (CFR and Eudralex), GMP and Regulatory.
- Good knowledge in RA and prior approval establishment RA inspections.
- Excellent communication skills
- Proven ability to communicate and to develop and maintain a network with all levels of management across functional, cultural boundaries
- Experience in project management including management of people from very different environment
If you have the following characteristics it would be a plus:
- Experience in people management
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
GSK Vaccines – Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
For further information, please visit www.gsk.com.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
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.
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.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Frist: 10-01-2026
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