Specialist Investigational Medicinal Product Quality

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Site Name: Belgium-Wavre

Posted Date: Sep 27 2021

Acts 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, the specialist QA GMP develops, assures and maintains the quality of the product and processes

− Standard procedures

− Quality audits/review

− Key Performance Indicators (KPIs)

− Step quality decision

Performs QA oversight for GMP production. Part of a team as QA for introduction of new product into our facilities (Multiple Building) and GMP production.

Your Responsibilities

Quality management

• Takes 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 one ore multiple aspects listed below :

• QA GMP operational activities
• Incoming material qualification
• quality systems
• Release (step quality decision)
• Ensures QA oversight of the GMP documentation
• Approves master production records and procedures for production
• Develops 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.
• Ensures all GMP productions are in line with product development evaluations, effective procedures and regulatory requirements
• Supports Qualification activities related to IM used in the frame of clinical projects/production (phase I/II or phase III but not used by commercial) following local TRDIM qualification SOP & tools (new process) and supports lifecycle management for those items.
• Ensures batches of the intermediate product related to the area of responsibility are released in a timely manner and in line with the product specification file
• Ensures QA oversight for deviations, complaints, change controls, OOS investigation, CAPA in his field of activities. Ensures there are reviewed and handled in a timely manner
• Ensures critical topics and risks are adequately managed and timely escalated to higher management
• Represents QA in all operational meetings related to the area of responsibility (staff meetings, deviation, CAPA, change control follow-up meetings,…). Responds to client requests in non-standard situations, investigating all the facts
• Performs internal audits
• Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirements
• Understands and manages complex technical/production problems and evaluates their potential impact on product quality.
• Compiles quality reviews. Understands key business/scientific issues in own area and takes them into account in work processes.
• Listens carefully, presents information clearly;
• Assures regulatory inspection readiness and provides QA expertise to act as a key spokesperson during external regulatory inspection. Ensures CAPA follow-up.
  

Why you?

Basic Qualifications

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

• Bachelor’s Degree in Pharmacy, Science, or an engineering discipline, OR equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment
• 2 years of Manufacturing/Quality experience in the Pharmaceutical industry.
• Specific competencies are required in term of QA operational & Incoming Materials for this job.
• Ability to read and write in English
  

Preferred Qualifications

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

• Ability to work independently and prioritize workload.
• Excellent oral and written communication skills.
• Strong interpersonal skills with an ability to enable and drive change.
• Problem identification and solving skills.
• Experience of working with multi-functional teams.
• Team player
  

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.

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

Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.

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.

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