IT Laboratory Operations Onsite Specialist Bucharest

IT Laboratory Operations Onsite Specialist
Bucureşti
Bucharest, Bucharest, Romania

Who we are

Purpose of Role

- Provides support in the process of creating the documentation specific to computerized systems: validation plan, user requirements, software and hardware configuration design documents.

- Creation of documentation associated with establishing the qualification status of production and laboratory equipment. This includes installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) documents.

- Be the site responsible for delivering, supporting and managing Quality systems and solutions in the laboratories and production area. These systems maybe standalone or interfaced with other systems.

- To be the site expert on all laboratory computer systems – LIMS (Labware), CDS (Empower),
- alone computer driven instrumentation and other applications identified by laboratory management.

- To manage and support standalone Laboratory / Quality systems, maintaining support for Interfaces and troubleshooting as and where required.

- Maintain the integrity of these systems and ensuring backup up solutions are in place by the global or local ITMU’s using standardised solutions.

- To ensure sufficient consideration is paid to all regulatory compliance requirements for system implementation and maintenance including c
GMP, computer systems validation, security and risk. Assist in the generation and execution of validation deliverables.

- To ensure appropriate service levels are developed and monitored, for support of laboratory IS systems working with the global team, external partners and providers of specific software related to the labs. Ensure support partners perform to the defined SLA and provide resolutions within the agreed timescales.

- Exchange and fix infrastructure compoments in the respective area 

- Coordinate between business / IT stakeholder management and global ITO teams

- Contribute to a continous documentation of the system landscape in the respective area

- Provide technical support as point of contact for IT for the site.

- New users onboarding preparing IT assets and tools.

- End-user desktop, laptops, office IT support. Installation support for various software on end user systems and equipments when required.

- Onboarding and mentoring of external IT Operations onsite engineers

- Offboarding support, collecting IT assets and sanitizing IT assets and keep in stock.

- Handling tickets on the internal Ticketing system (Service
Now) platform.

- IT Asset Management. Manage Hardware rollouts.

- Perform troubleshooting, parts replacement, system upgrades, and basic deployments and repair on sites where required.  

- IP phone, Video conference support, Printers support.

- Basic installation and maintenance of technical products.

- Installs, maintains, and optimizes desktop /notebook configurations. Reviews, troubleshoots, and approves operational quality desktops, notebooks, printers, and associated peripherals.  

- Ensure that all work carried out is in compliance with the required standards conforming to company c
GMP, c
GLP, SOP, Health & Safety Specifications, Environmental and Regulatory requirements.

Knowledge, Skills and Abilities 

- IT Business experience with desktop, mobile computing and/or network, including problem analysis/resolution, and installation.  

- Experience across a broad range of Quality / Laboratories systems and applications in the Pharmaceutical Industry.

- Knowledge of Microsoft Windows OS, Network equipments, Internet connectivity and knowledge of computer networking / server and compute environments.

- Knowledge of PC Hardware configurations and troubleshooting

- Strong written, numerical and verbal communications skills. Compliance, Validation Gx
P experience.

Qualifications and Accreditations

- High School diploma in Computer Science, Management Information Systems, Engineering or related field

- Bachelor's Degree in computing, science or a related subject / equivalent field experience - preferable

- Minimum 2 years experience across various IT systems 

- Pharma Validation experience – GXP / GMP – preferrable. Experience in the pharmaceutical, chemical or food industry is an advantage

- Very good command of English 

Competencies

• Collaboration - The ability to work effectively with peers, partners and others, to positively impact performance

• Planning & Organizing - Adopts a structured approach, establishes plans, priorities and goals that are clear and logical; Organizes resources.

• Drive & Resilience - Demonstrates drive and persistence to meet and exceed objectives; remains positive in challenging situations and recovers quickly from setbacks.

• Effective Communication - Communicates clearly to others and ensures understanding. Adjusts style of communication appropriately to the audience.

• Leading Others - The ability to empower, grow, develop and inspire high performing teams and individuals.

• Change & Adaptability - The ability to recognize and act upon change as a necessity to achieve goals.  

• Analytical Thinking & Problem Solving - Analyses information effectively; identifies the causes of problems and provides realistic and practical solutions to address them.

• Customer Focus - Identifies and understands the customer’s needs. Focuses on meeting their needs, ensuring both satisfaction and a continuing business relationship.

• Integrity - Maintains high standards of honesty and trustworthiness. Considers ethical implications of issues and decisions.