- Partner with the IT Computer System Validation Manager and other departments to develop and execute comprehensive Computerized System Validation (CSV) plans for automated equipment, processes, and systems.
- Conduct thorough risk assessments to identify potential data integrity vulnerabilities and ensure compliance with regulations like CFR Part .
- Develop and implement robust data integrity assessments and data mappings for new systems, aligning them with established Data Integrity plans and procedures.
- Create clear and concise test scripts to verify that systems meet data integrity requirements, user specifications, and regulatory guidelines.
- Write well-defined Software/Computer Validation Protocols according to client policies and best practices./
- Perform computerized system validations adhering to cGMPs, site procedures, and regulations (FDA, DEA, etc.).
- Coordinate and execute validation activities as outlined in approved protocols, ensuring a smooth and efficient process.
- Analyze test data to make informed recommendations on computer software acceptance or rejection.
- Prepare comprehensive Final Validation Reports following FDA certification principles.
- Advise the IT Computerized System Validation Manager on the adequacy and completeness of validation protocols.
- Provide technical expertise regarding validation plans and protocols, ensuring alignment with Data Integrity requirements and established site procedures.
- Contribute to the development of user and design specifications for relevant systems, ensuring functionality and data integrity.
- Review and approve validation documents for various equipment, processes, and systems used throughout the pharmaceutical manufacturing environment.
- Manage and maintain validation documentation throughout the system lifecycle, ensuring all records are accurate and up-to-date.
- Actively support investigations related to manufacturing, laboratories, facilities, and utilities. Provide an IT perspective on root cause analysis to identify and address potential issues.
- Participate in risk analysis processes for IT-related events requiring immediate resolution, ensuring data integrity and process continuity.
- Maintain accurate and complete records in the Infinity System for audit observations, investigations, change control, and corrective actions (CAPAs).
- Bachelor's degree in Computer Science, Engineering, or a related scientific field (preferred).
- Five () years of experience in computerized system validation within the pharmaceutical or biopharmaceutical industry ( strongly preferred ).
- Strong understanding of laboratory instruments, pharmaceutical manufacturing processes, and GMP regulations is essential.
- In-depth knowledge of relevant GMP, FDA regulations ( CFR Part ) and Data Integrity principles (Risk Assessment, Data Mapping, etc.).
- Proficiency in network communication protocols (TCP/IP) .
- Experience with GAMP validation methodology is a plus.
- Excellent written and verbal communication skills in English and Spanish are required for effective collaboration.
- Proven ability to revise and create technical documentation in English using MS Office applications.
- Strong analytical and problem-solving skills with a focus on root cause analysis are essential for identifying and resolving data integrity issues.
- Attention to detail and accuracy are paramount in this role.
- Proficiency in computer systems (Microsoft Office) and data collection software (databases) like Infinity and SAP.
- Ability to analyze data, detect deviations, interpret results, and identify inconsistencies.
- Self-motivated, creative, and a team player with a strong work ethic.
- Willingness to work irregular hours, rotative shifts, weekends, and holidays as needed to ensure project deadlines are met. Why RCM:
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Data Integrity Specialist - Manatí, Puerto Rico - RCM Technologies, Inc.
Descripción
Job Title: Data Integrity/CSV SpecialistJob Function: Collaborate with the IT Computer System Validation Manager (or designee) and cross-functional teams across the site to develop, execute, and optimize Software/Computer Validation Plans for automated equipment, processes, and systems.
Length of Assignment : months +
Location: Manati, PR (On-Site)
Scope of Job
Are you a detail-oriented professional passionate about data integrity and ensuring quality in the pharmaceutical industry? Do you have a strong understanding of regulations and a knack for problem-solving? If so, we want you on our team RCM is seeking a highly motivated Data Integrity Specialist to join our team at a leading pharmaceutical company in Manati, PR. You will play a critical role in safeguarding the accuracy and integrity of data generated by automated equipment, processes, and systems used in the manufacturing and testing of pharmaceutical products.
Responsibilities:
Qualifications:
Join a growing company with a strong commitment to quality and compliance. You will have the opportunity to work with a talented team and make a significant impact on ensuring the integrity of data used in the development and manufacturing of critical healthcare products. RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over , clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
RCM is an equal opportunity employer.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
