Job Opportunities in Costa Rica
September 30, 2024
Accenture
Heredia
OTHER
Strategy & Consulting - Global Network - Industry X - Computerized Software Validation Consultant
Join Our Global Consulting Network and Expand Your Horizons!
Are you ready to take your career to new heights? At the Global Network, we are more than just a team; we are a thriving community of over 10,000 professionals operating from key locations around the world. We specialize in providing top-tier consulting expertise across various industries and functional areas, including life sciences, energy, supply chain operations, finance, and talent management.
Why Choose Us?
Global Exposure: Work on international projects and gain invaluable insights into diverse cultures and business practices.
Specialized Development: We don’t just work across broad spectrums; we ensure you develop deep expertise in specific areas of management consulting, enhancing both your professional value and expertise.
Dynamic Work Environment: Our work is fast-paced and challenging, pushing you to grow quickly and continuously improve. It’s not just about meeting expectations; it’s about exceeding them and making a significant impact.
Innovation at the Core: At the Global Network, innovation isn't just a buzzword—it's a fundamental part of how we operate. We leverage cutting-edge technologies and innovative strategies to solve complex problems and deliver novel solutions that keep our clients ahead in a rapidly changing world.
We are driven by a commitment to excellence and a passion for delivering results that matter. If you are ambitious, talented, and ready for a challenge, we want to hear from you. Reach out, join our network, and start a conversation that could lead to your next big opportunity.
Let’s build a better future together!
Industry: Pharmaceutical / Biotechnology / Medical Devices
Overview: We are seeking a highly skilled Computerized Software Validation Lead with extensive experience in FDA 21 CFR Part 11 and Good Practice (Gx P) regulations. The ideal candidate will be responsible for overseeing the validation of computerized systems to ensure compliance with regulatory standards, facilitating quality assurance processes, and leading cross-functional teams in the pharmaceutical or biotechnology industry.
Key Responsibilities:
Are you ready to take your career to new heights? At the Global Network, we are more than just a team; we are a thriving community of over 10,000 professionals operating from key locations around the world. We specialize in providing top-tier consulting expertise across various industries and functional areas, including life sciences, energy, supply chain operations, finance, and talent management.
Why Choose Us?
Global Exposure: Work on international projects and gain invaluable insights into diverse cultures and business practices.
Specialized Development: We don’t just work across broad spectrums; we ensure you develop deep expertise in specific areas of management consulting, enhancing both your professional value and expertise.
Dynamic Work Environment: Our work is fast-paced and challenging, pushing you to grow quickly and continuously improve. It’s not just about meeting expectations; it’s about exceeding them and making a significant impact.
Innovation at the Core: At the Global Network, innovation isn't just a buzzword—it's a fundamental part of how we operate. We leverage cutting-edge technologies and innovative strategies to solve complex problems and deliver novel solutions that keep our clients ahead in a rapidly changing world.
We are driven by a commitment to excellence and a passion for delivering results that matter. If you are ambitious, talented, and ready for a challenge, we want to hear from you. Reach out, join our network, and start a conversation that could lead to your next big opportunity.
Let’s build a better future together!
Industry: Pharmaceutical / Biotechnology / Medical Devices
Overview: We are seeking a highly skilled Computerized Software Validation Lead with extensive experience in FDA 21 CFR Part 11 and Good Practice (Gx P) regulations. The ideal candidate will be responsible for overseeing the validation of computerized systems to ensure compliance with regulatory standards, facilitating quality assurance processes, and leading cross-functional teams in the pharmaceutical or biotechnology industry.
Key Responsibilities:
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Validation Leadership:
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Lead the validation efforts for computerized systems in accordance with FDA 21 CFR Part 11 and Gx P guidelines.
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Develop and implement validation strategies, plans, and protocols for new and existing software systems.
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Lead the validation efforts for computerized systems in accordance with FDA 21 CFR Part 11 and Gx P guidelines.
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Regulatory Compliance:
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Ensure all validation activities are conducted in compliance with regulatory requirements and internal quality standards.
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Maintain current knowledge of industry regulations, standards, and best practices.
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Ensure all validation activities are conducted in compliance with regulatory requirements and internal quality standards.
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Documentation and Reporting:
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Oversee the preparation of validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
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Review and approve validation documentation to ensure completeness and accuracy.
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Oversee the preparation of validation documentation, including User Requirements Specifications (URS), Functional Specifications (FS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
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Cross-Functional Collaboration:
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Collaborate with IT, Quality Assurance, and other departments to ensure alignment on validation processes and requirements.
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Provide guidance and support to project teams on validation-related issues.
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Collaborate with IT, Quality Assurance, and other departments to ensure alignment on validation processes and requirements.
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Training and Mentorship:
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Train and mentor team members on computerized software validation processes and regulatory compliance.
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Conduct workshops and presentations to promote best practices in validation.
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Train and mentor team members on computerized software validation processes and regulatory compliance.
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Risk Management:
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Conduct risk assessments related to software validation and develop mitigation strategies.
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Monitor and address any validation-related issues that arise during the lifecycle of software systems.
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Conduct risk assessments related to software validation and develop mitigation strategies.
Required Qualifications:
#LI-LATAM
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Language: Fluent in English
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Education:
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Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
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Advanced degree or certifications in relevant fields is a plus.
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Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field.
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Experience:
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5+ years of experience in computerized software validation within the pharmaceutical, biotechnology, or medical device industries.
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Strong understanding of FDA 21 CFR Part 11 and Gx P regulations.
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5+ years of experience in computerized software validation within the pharmaceutical, biotechnology, or medical device industries.
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Skills:
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Excellent knowledge of validation methodologies, tools, and techniques.
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Strong analytical and problem-solving skills.
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Exceptional communication and interpersonal skills, with the ability to collaborate effectively across teams.
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Proficient in validation documentation and project management software.
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Excellent knowledge of validation methodologies, tools, and techniques.
#LI-LATAM
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