Data Integrity Specialist - RCM Technologies (USA), Inc.

Job Title: Data Integrity Specialist
Job Function: Provide support to the sites's IT Computer System Validation Manager (or designee) and the site's areas in development and execution of software/computer validation plans for automated equipment, processes, and systems.
Job Type: 12 months full time contract 
Location: Manati, PR (On-Site)

About RCM:
RCM IT & Life Sciences is a leading provider of IT Business Solutions and Engineering Services to over 1,000 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.

Scope of Job

RCM is looking for a Data Integrity Specialists for our pharmaceutical company client.

Primary Responsibilities

• Works with the sites's IT Computer System Validation Manager (or designee) and the site's areas in development and execution of software/computer validation plans for automated equipment, processes, and systems.
• Identifies computerized systems validation needs through the development of risk assessment, including data integrity requirements, following sites procedures.
• Develop data integrity assessments and data mappings for new systems aligned with site Data Integrity master Plan and applicable processes and procedures.
• Develop test scripts to confirm the computerized systems are in compliance with data integrity requirement, User and Design Specification requirements, and aligned with the Computerized System Program and applicable processes and procedures.
• Develop Software/Computer Validation Protocols according to client policies on computerized systems validations.
• Performs computerized system validation in conformance with cGMPS, site procedures, corporate policies and applicable rgulations (FDA, DEA, etc)
• Coordinates and executes validation activities as per approved Protocols.
• Recommend acceptance of computer software, as determined from the test performed on the protocol. Analyzes data in order to determine acceptability. Recommends action to be taken if the software is not accepted.
• Generates Final Validation report in accordance with actual FDA certification concepts.
• Advises the IT Computerized System Validation manager (or designee) on the adequacy/completeness of Software Operational Qualification Protocols for his/her approval.
• Provides technical counsel on issues and concerns regarding validation plans and protocols design assuring the system comply with data integrity requirements and site processes and procedure.
• Provide input and/or develop user and design specifications and/or functional requirements for applicable systems.
• Reviews and approves the CSV Installation and Operational Qualification Protocol (IOQ) for computerized systems, and/or automated manufacturing/laboratory equipment, processes, and systems with respective reports.
• Reviews and approves the Process/Laboratory Traceability Matrix document, and Validations reports among others.
• Review and approve equipment, utilities and facilities qualification and system lifecycle documentation.
• Reviews and approves all equipment, utilities, facilities, process, product and computer systems validation protocols and reports, change control documentation, reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology laboratory.
• Review/Approve equipment/facilities/systems (including Qualified Building Automation Systems, QBASM and QBAS) validation documents such as User Requirements Specifications (URS), Design Specifications(DS), Risk Assessment(RA), Data Mapping/Data Flow/data Integrity, Audit Trail Review Applicability, Traceability Matrix, Installation, Operational and Performance Qualification, Validation Plan and Reports, among others.
• Reviews/approve test script and manage revision/approval of the deviation investigation process (initial phase, execution, final phase/approval) in the ALM environment or any other application system.
• Reviews and approves IT procedures related to computerized and ensures compliance of all procedures (SOP's-Operational and/or Administrative) to avoid potential regulatory and compliance issues.
• Supports, review and approves actively the investigation process occurred in manufacturing, warehouse, calibration, analytical and microbiology laboratory, facilities, and utilities areas related to process, products, utilities among others providing coaching from IT perspective.
• Provides scientific input into investigations management to assure root cause and CAPAs are aligned with the opportunities identified to perform a systematic approach.
• Supports risk analysis process when an IT event has happened that cannot be solved immediately. This assessment needs to be completed to continue or prior to resumption of manufacturing/laboratory process.
• Manages audit observation, investigations, change control and CAPAs records in Infinity System on timely manner.
• Reviews and approved Commissioning Packages for utilities, manufacturing and Laboratory Facilities and equipment.
• Perform Computerized System Validation (CSV) activities following client CSV Standard Procedure.

Qualifications:

• Knowledge of laboratory instruments operations and background in pharmaceutical products manufacturing environment.
• Strong knowledge of relevant GMP, FDA, 21 CFR Part 11 and Data Integrity Regulations (Risk Assessment, Data Mapping etc), EU regulations and the ability to interpret and apply them for intended use.
• Knowledge with network communications protocol (i.e. TCP/IP)
• Acquainted with GAMP5 methodology for validations.
• Good skills revising validation/commissioning, and technical documentation in English and using MS Office applications.
• Fully bilingual (Spanish/English) communication skills, both written and verbal.
• Self-motivated, creative and teamwork oriented
• Technical and scientific capability to make firm decisions and recommendations.
• Excellent interpersonal skills and the ability to interact with people at all levels
• Sense of urgency and analytical thinking
• Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP
• Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results
• Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe)
• Willing to work irregular hours, rotative shifts, weekends and holidays when needed.

Education & Certifications

• Bachelor's degree in computer science, engineering or science.
• Training in validation methodologies, technologies and process control computer systems.
• Five (5) years of experience in computerized system validation of pharmaceutical or biopharmaceutical industry.

Equal Opportunity Statement
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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.