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We ensure that all operations, digital or otherwise, meet the latest quality and compliance standards. No detail goes unnoticed by our quality and compliance experts, who stay informed of evolving standards such as GDPR and ISO. Audits are conducted regularly to keep our standards high, while strict quality control guidelines are adhered to. As a quality and compliance expert, you’ll take credit for making sure everything meets our high standards of efficiency, security and legal compliance.
Job Responsibility:
Gathering, analysing and documenting requirements for electronic Master Batch Record (eMBR) changes within the PAS-X Manufacturing Execution System (MES)
Collaborating with cross-functional teams, including engineering, quality assurance, and operations, to ensure that the eMBR enhancements align with business goals and regulatory requirements
Gathering and analysing business requirements, creating detailed specifications, and acting as a liaison between business and technical teams
Requirements:
Master’s degree in Business Administration, Information Technology, Biopharmaceuticals or a related field
3-5 years of relevant work experience
Proven experience as a Business Analyst, preferably in a GMP environment
Knowledge of a pharmaceutical manufacturing process, including batch processing, recipe management, and quality control
Ability to write functional specifications
Affinity with automation, software, data and programming
Ability to work collaboratively with cross-functional teams to lead and deliver projects end-to-end
Proficient in using business analysis tools and software
Excellent analytical and problem-solving skills
Excellent networking and communication skills
Ability to work independently and take initiative to deliver tasks in time
Knowledge of process mapping and process modelling techniques
Nice to have:
Knowledge about PAS-X
What we offer:
Mobility options (including a company car), insurance coverage, meal vouchers, eco-cheques
Continuous learning opportunities through the Sopra Steria Academy
The opportunity to connect with fellow Sopra Steria colleagues at various team events
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