QA Specialist EM/Ops-PSMMC

Jobinhalt

Site Name: Belgium-Wavre
Posted Date: Jul 9 2021

Job Purpose

Raises and maintains the status of quality in the organisation and enables a company to promote itself as one that provides quality goods and services. Involves Total Quality Management (TQM) programmes and the development of standard procedures in accordance with GSK standards and cGMP Regulations.

Your Responsibilities

• Masters the key QA activities related to production, QC, maintenance and calibration, warehouse, CSV, validation, project activities in his/her area of responsibility
• Ensures batches of the intermediate product related to the area of responsibility are released in a timely manner
• Ensures deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in a timely manner
• Supervises a team of technicians, distributes their work and is responsible for their training and development plan
• Represents QA (decision responsibility) in all meetings related to the area of responsibility (staff meetings, deviation, CAPA, RPCPage 2 / 5 follow-up meetings, ICG project, …)
• Ensures critical topics are adequately escalated to higher management
• Acts as QMS subject matter expert (SME) (= knowledgeable of the QMS standard related to the area of expertise, ensure all requirements of the standards are cascaded in SOP’s, accountable for gap analysis and related action plans)
• Is the preferred front line spokesperson during inspection for the subject of expertise as well as for all operational aspects belonging to the area of responsibility
• Leads local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
• Performs internal and act as external supplier audits
• Understands technical/production complex problems and evaluates potential impact on product quality
• Assesses quality review files and draws adequate conclusions
• Provides QA expertise support to new product introduction projects and related validations
  
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Scientific university degree (Pharmacist, Engineer or equivalent)
• French is a must, English is a plus: written and spoken
• Minimum 5 years of experience in a Pharmaceutical/Bio/Medical device environment or equivalent
  
  

Preferred Qualifications

If you have the following characteristics it would be a plus:

• Knowledge of GMP regulated environment
• Aseptic Practices
• Environmental Monitoring programs for clean rooms (viable and non viable) operators and critical utilities
• Cleaning & Sanitization
• Sterilization
• Media simulation
  
  

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.

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.

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.

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.

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