Specialist QA Incoming Material– qualifications

Job content

Site Name: Belgium-Wavre
Posted Date: Jul 18 2021

Job Purpose

• Ensure quality of suppliers and Incoming materials for GSK Vaccines Belgium site.
• Manage and ensure appropriate QA oversight of qualification and life-cycle activities of incoming materials - including initial qualification, investigations, CAPAs, supplier notifications and internal changes - in order to ensure a robust supply pipeline within GSK Vaccines.
• Make quality decisions on IM (Incoming Materials).
• Understand and deploy regulatory constraints (GMP, ISO …), as well as internal procedures, related to management of incoming materials.
• Ensure implementation of QA IM quality improvement plans and maintain inspection readiness status.
  
  

Your Responsibilities

In this role you,

• Understand and manage autonomously quality aspect of suppliers and materials qualifications in partnerships with key stakeholders (SPU IM stakeholders/procurement/QSIM/QC/Engineering/provisioning/MSAT).
• Perform Quality Oversight on most investigations (deviations and market complaints) in partnership with SPU IM Ops, QSIM, MSAT, QC, Belgium manufacturing facilities and suppliers to identify and follow up root causes and CAPA’s, as well as IM product impact assessment and root cause.
• Perform Quality Oversight on local supplier change notifications to ensure appropriate review and implementation.
• Perform Quality Oversight on local change controls related to IM
• Escalate quality issues to stakeholders through appropriated escalation processes.
• Support supplier quality system audits on request and assess supplier capability to meet product requirement specifications.
• Manage current regulatory requirements, as well as internal, environment related to incoming materials.
• Promote a customer focus spirit. Cultivating a network of collaborative internal relationship and supplier network.
• Promote continuous improvement mindset and initiatives
  
  

Why you?

Basic Qualifications

We are looking for professionals with the following required skills to achieve our goals (must-have):

• Master’s in Engineering/Biology/Chemistry, Pharmacist, PhD Degree in a relevant scientific, quality or technical discipline and experience in (bio)pharmaceutical manufacturing and/or quality operations.
• Be able to understand main regulatory constraints and main vaccines manufacturing processes.
• Sciences (biology, chemistry, pharmacist …) or engineering degree or other technical related fields.
• Relevant to position demands to ensure understanding of production processes and GMP environment

• Knowledge of regulatory and quality system requirements
• Good verbal and written communications skills to ensure issues, risks and opportunities are well understood by all parties and that effective actions are put in place.
• Ability to function efficiently in a matrix organization in order to ensure effective use of resource and communication of issues to all impacted functions.
• Experience with Microsoft Office applications and have the ability to learn new software applications such as SAP.
• Ability to influence stakeholders to ensure implementation of appropriate regulatory requirements and quality standards.
• Ability in planning and executing pharmaceutical supplier audits to identify, manage, correct and reduce significant risks / non-compliances.
  
  

Preferred Qualifications

The following characteristics are assets (nice-to-have):

• Ability to function effectively across multiple functions.
• Knowledge of technologies used in material supply base.
• Knowledge of cGMP regulatory requirements and standards.
  
  

Why GSK?

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.

Our Department

The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for

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.