Senior IT Operations Support & Compliance Specialist
About the Job
The position primary objective is the support and system administration of computerized site cGMP‘s quality systems for Manufacturing, QC/QA , EHS, Maintenance and Supply Chain departments system including network, communication and devices. Provides support of Bristol-Myers Squibb manufacturing facility to ensure that cGMP’s related IT activities are properly maintained in accordance to all Federal, State and Corporate Regulations and therefore, supporting BMS’s business goals. Conducts and/or supports the design, development and execution of validation plans and protocols for the Quality Assurance/Quality Control Laboratories, operations. Provides management and troubleshooting support for Manufacturing, QC/QA, EHS, Maintenance and Supply Chain and QA/QC computerized systems under the IT Department responsibility. Must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Assesses, recommends, validates and implements the quality systems to support the site’s Manufacturing, QC/QA, EHS, Maintenance and Supply Chain management and coordinates and executes the installation, maintenance, qualification, validation and upgrade of the new and existing systems. Develops the validation documentation of computerized systems for Manufacturing, QC/QA, Maintenance and Supply Chain Systems and performs the activities (as per approved Validation plans and protocols). Administrates, maintains and executes change control activities related to Manufacturing and Quality Computerized Systems. Maintains up to date site’s Computer System Validation Master Plan and CSV equipment inventory. Advises the IT Site management on the adequacy/completeness of qualification protocols for approval. Generates and maintains the related Standard Operating Procedures and performs required system maintenance activities. Provides ongoing training to users on procedures, protocols and computer systems. Performs system security and administration tasks for cGxP (QC/QA, EHS, Maintenance, Supply Chain and critical business information systems\: such as\: (1) user accounts; (2) back/up and restore (3) management of hardware on the LAN; (4) security administration including granting of file/directory permissions,(5) performance monitoring and (6) database optimization and analysis. Provides technical expertise in database and application to support in-house development programming on new or existing business applications packages, technical advice on the selection of equipment and system software for data acquisition and archival systems for Manufacturing, QC/QA, EHS, Maintenance and Supply Chain, technical direction on issues and concerns regarding validation plans and protocol design and guidance in the design of specifications and/or functional requirements for computerized systems. Recommends acceptance of the computer system, as determined from the tests performed on the Protocol and actions to be taken if the system is not accepted in addition, analyzes data in order to determine acceptability and generate Final/Validation Report in accordance with actual FDA concepts. Performs project management functions for the execution, implementation, commissioning of the new systems and project management for computerized systems validation projects under his responsibilities and prioritize projects and schedules as needed. Responsible for site periodic review of computerized systems validation evaluation. Responsible for the implementation and support of GMS IT initiatives of Bristol-Myers Squibb Company policies, directive and guideline on computerized systems validation. Generates and/or execute and recommend action(s) to be taken whenever additions, alterations or changes are to take place in computerized systems. Coordinates and maintains a training program together with the KT department. Requisition outside resources to assist in project implementation as needed. Determines work procedures, prepares work schedule and expedites workflow to maintain compliance in all aspects.Bachelor’s Degree in Science (Chemistry, Biology or Engineering). Training in computer validation methodologies, technologies. Five (5) years of computerized system administration in a pharmaceutical manufacturing operations with proven skills in management and implementation of computerized system validation projects and developing computerized system validation plan and protocols. Customer Service Oriented. Knowledge and experience in Software Life Development Cycle (SLDC) and 21 CFR Part 11 regulations. Ability to impact and influence people/areas with and outstanding company to deliver superior business results. Through knowledge of cGMP and FDA, EMA, ANVISA and other regulation is a must. Experience and Knowledge in Database development, design, implementation and tuning. Excellent communication skills (oral, written and reading) in Spanish and English. Proven skills in projects management and validation of manufacturing and quality related systems. Knowledge of Client Server environment, UNIX, NT, Windows 2008 or higher, Data communications equipment\: Routers, Switches, LAN/WAN. Knowledge of business and maintenance applications like SAP and CMMS (e.g. Maximo). Availability to support site operations during weekdays, weekends, holidays and after hours as needed.