Quality Assurance Analyst
Il y a 5 jours
Geel, Flanders, Belgique
MindCapture
Temps plein
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Are you a Quality Assurance professional with 3 to 5 years of experience in a GMP environment? Are you passionate about digital transformation and ensuring quality in pharmaceutical manufacturing?
We are looking for a QA Specialist to support an exciting digitalisation project within a pharmaceutical manufacturing environment. You will play a key role in transitioning paper manufacturing batch records into electronic batch records while ensuring compliance with GMP standards.
What's offered?
Ready to grow your career and make real impact? Join MindCapture
We offer
competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car). You also get the opportunity to shape your future through personalised training and development. At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most. You will work as a MindCapture consultant for an international market leader in the biopharma industry.
Job Description
• Prepare and review quality documentation related to the digitalisation project, including project notes and quality plans.
• Review and approve electronic master batch records within electronic manufacturing execution systems.
• Develop and review project documentation, including procedures and risk assessments, with a focus on deviation prevention and human error prevention.
• Ensure compliance with SOPs, global quality standards, regulatory requirements and product registrations for clinical and commercial manufacturing.
• Provide Quality Assurance support to manufacturing operations throughout the implementation of electronic batch records.
• Collaborate with different departments to ensure successful project execution and alignment with quality requirements.
• Identify potential quality or compliance issues and escalate them appropriately to supervisors or management.
Requirements:
• Master’s degree in a scientific discipline or equivalent experience.
• 3 to 5 years of professional experience in a GMP regulated environment, preferably within Quality Assurance.
• Strong knowledge and understanding of cGMP requirements and their application in pharmaceutical manufacturing.
• Experience working with electronic batch records and related digital manufacturing systems.
• Solid understanding of Quality Assurance processes and quality documentation.
• Excellent attention to detail, accuracy and a strong commitment to quality.
• Ability to work independently, take ownership of responsibilities and proactively identify potential issues.
• Strong communication skills and the ability to collaborate effectively with different departments.
• Excellent technical writing and documentation skills.
• Good command of English, both written and spoken. Are you ready to make a real difference in healthcare? Join our dynamic team and help drive innovation in pharma. Apply now and let’s make an impact together Want to learn more? Discover all opportunities at www.mindcapture.com. If MindCapture sees a potential fit, we’ll get in touch as soon as possible. If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep
your profile
in mind for future roles that could suit you better.
We offer
competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car). You also get the opportunity to shape your future through personalised training and development. At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most. You will work as a MindCapture consultant for an international market leader in the biopharma industry.
Job Description
• Prepare and review quality documentation related to the digitalisation project, including project notes and quality plans.
• Review and approve electronic master batch records within electronic manufacturing execution systems.
• Develop and review project documentation, including procedures and risk assessments, with a focus on deviation prevention and human error prevention.
• Ensure compliance with SOPs, global quality standards, regulatory requirements and product registrations for clinical and commercial manufacturing.
• Provide Quality Assurance support to manufacturing operations throughout the implementation of electronic batch records.
• Collaborate with different departments to ensure successful project execution and alignment with quality requirements.
• Identify potential quality or compliance issues and escalate them appropriately to supervisors or management.
Requirements:
• Master’s degree in a scientific discipline or equivalent experience.
• 3 to 5 years of professional experience in a GMP regulated environment, preferably within Quality Assurance.
• Strong knowledge and understanding of cGMP requirements and their application in pharmaceutical manufacturing.
• Experience working with electronic batch records and related digital manufacturing systems.
• Solid understanding of Quality Assurance processes and quality documentation.
• Excellent attention to detail, accuracy and a strong commitment to quality.
• Ability to work independently, take ownership of responsibilities and proactively identify potential issues.
• Strong communication skills and the ability to collaborate effectively with different departments.
• Excellent technical writing and documentation skills.
• Good command of English, both written and spoken. Are you ready to make a real difference in healthcare? Join our dynamic team and help drive innovation in pharma. Apply now and let’s make an impact together Want to learn more? Discover all opportunities at www.mindcapture.com. If MindCapture sees a potential fit, we’ll get in touch as soon as possible. If you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll gladly keep
your profile
in mind for future roles that could suit you better.