Operational QA, MPU LVV

Job description

Details:

Job Purpose:

- Coordinator QA operational (MPU LVV – bulk/formulation activities) :
o Raise and maintains the status of quality in the organization
o Develops, assures and maintains the quality of the product and processs.

Key Responsibilities:

- Ensure quality oversight of all activities related to the area of responsibility
- Ensure batch of the intermediate product related to the erea of responsibility are released in timely manner
- Ensure deviations, complaints, change controls, OOS investigation, maintenance and calibration plans are reviewed and handled in timely manner
- Ensure critical topics are adequately and timely escalated to higher management
- Represents QA in all operational meetings related to the area of responsibility
- Performs internal audits, shopfloor, gemba's
- Contributes to local and/or transversal improvement projects to ensure the compliance level is maintained in line with cGMP and GSK standard requirement
- Provides QA support to new projects and related validation activities
- Understands technical/production problems and evaluates their potential impact on product quality. Escalates complex problems to N=1

Our Offer:

At GSK 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. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

The department:

Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
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 the release of final products made in Belgium and abroad.
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.

Our Company:

GSK is a science-led global healthcare company with a mission to help people do more, feel better, live longer. At GSK, we research, manufacture and make available a broad range of medicines, vaccines and consumer healthcare products.

GSK Vaccines is a world's leading company, involved in vaccine research, development and production. We have 16 candidate vaccines in development and our broad portfolio of around 40 vaccines prevent illnesses such as hepatitis A, hepatitis B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis. Globally, we have more than 16.000 people working to deliver vaccines safely, every day, to people in 90% of the world's countries. In 2014 we distributed around 800 million doses of vaccine, 80% of them to least developed, low and middle income countries.
For further information, please visit www.gsk.com.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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.

Desired profile

Basic qualifications:

- Scientific university degree (pharmacist, Engeneer or equivalent)
- Minimum 2 years of experience in a pharmaceutical/BIO/Medical device environment or equivalent

Preferred qualifications:

- Knowledge of GMP regulated environment and aseptic environment
- Good knowledge of English