Job Opportunities in Costa Rica
August 9, 2024
Accenture
Heredia
OTHER
Validation Lead
Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 750,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. We are uniquely able to deliver tangible outcomes because of our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song. These capabilities, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities. Visit us at www.accenture.com.
We are seeking a highly experienced and motivated Validation Lead to join our Quality Assurance team. In this critical role, you will be responsible for leading and overseeing all aspects of computer system validation (CSV) for our pharmaceutical products, ensuring compliance with Gx P regulations.
Responsibilities:
#LI-LATAM
We are seeking a highly experienced and motivated Validation Lead to join our Quality Assurance team. In this critical role, you will be responsible for leading and overseeing all aspects of computer system validation (CSV) for our pharmaceutical products, ensuring compliance with Gx P regulations.
Responsibilities:
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Lead and manage the validation life cycle for computerized systems used in the development, manufacturing, and distribution of pharmaceutical products.
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Develop and implement comprehensive validation plans, protocols, and test scripts in accordance with Gx P requirements (e.g., c GMP, GAMP 5, ICH Q2).
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Manage and mentor a team of validation specialists, providing training and guidance on validation best practices.
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Oversee the execution of validation activities, including installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and user acceptance testing (UAT).
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Analyze and document validation results, ensuring they meet predefined acceptance criteria.
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Identify, document, and track deviations and CAPAs (Corrective and Preventive Actions) related to validation activities.
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Maintain and update validation documentation, ensuring its accuracy and completeness.
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Collaborate with cross-functional teams (IT, Development, Operations) to ensure successful system validation and implementation.
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Stay up-to-date on the latest Gx P regulations and industry best practices for computer system validation.
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Conduct risk assessments to identify potential validation gaps and propose mitigation strategies.
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Continuously improve the validation process for efficiency and effectiveness.
#LI-LATAM
Qualifications
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Minimum 5 years of experience in computer system validation CSV , preferably within the pharmaceutical industry.
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Advanced English skills: writing, reading and speaking
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Proven leadership experience in managing and mentoring a validation team.
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Knowledge of Gx P regulations and their application to CSV.
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Strong understanding of software development lifecycle SDLC methodologies.
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Experience with validation methodologies and tools e.g., V Model, risk assessments, traceability matrices .
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Excellent communication, interpersonal, and organizational skills.
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Ability to manage multiple projects simultaneously and prioritize tasks effectively.
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Strong analytical and problem solving skills.
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Excellent attention to detail and a commitment to quality.
What we offer
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Health and Life Insurance
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Accenture days, 3 additional vacation days
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On site doctor
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Birthday leave
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Internet reimbursement
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Graduation bonus
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Referral bonus
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And more!
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