IT CSV Consultant

Singapore

Details

Responsibilities

Provide consulting service in the area of IT / OT aspects of QC laboratory in the pharmaceutical industry.
Strategize and execute data migration tasks, including backup, and archiving processes.
Perform configuration of QC laboratory equipment applications.
Perform PC imaging.
Execute audit trail reviews, user access reviews, manual password resets, and critical settings verification in line with Data Integrity risk assessments or security assessments.
Identify and respond to cybersecurity threats, collaborating with Cybersecurity teams to address potential security breaches or lockouts.
Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk impact or functional assessment(s)).
Develop and execute FAT/SAT test scripts, qualification protocols and reports based on industry best practices and Client’s / Solution Provider’s documentation system.
Review, analyze and evaluate system functions and processes to deliver validation deliverables.
Develop testing / qualification approach using science- or risk-based approach that meets regulatory expectation.

Professional Skills and Experience

At least Bachelor’s degree in technical discipline such as Engineering, Science or IT. Graduates of related discipline may also apply.
Proficient in handling and configuring laboratory applications such as Tiamo, HPLC, Endoscan, TOC, SOLOVPE, etc.
Have at least some understanding of network systems, including firewalls, DNS, IP management, and cable patching.
Skilled in PC imaging using tools such as Acronis or Macrium to ensure efficient system recovery and deployment.
Have performed software configurations, including PC setups per in-house IT requirements and remote desktop tools like Dameware.
Experience in cybersecurity threat identification.
Experience in paperless validation system.
Ability to communicate quality and risk-related concept to technical and non-technical audiences.
Good written and oral communication skills, presentation, and data analytics with center of excellence.
Demonstrated ability to work as both a team player and independently.
Good organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detail.
Foundational understanding of ICH Q7/Q9, 21 CFR Part 11, EU Annex 11 and regulatory requirements.
Knowledge of ISO9001, GAMP5, ISA88, ISA95, and other relevant pharmaceutical standards / best practices.

About NNIT

NNIT is a public listed company who specializes in IT solutions to life sciences internationally, and to the public and enterprise sectors in Denmark. We focus on high complexity industries and thrive in environments where regulatory demands and complexity are high. We advise on and build sustainable digital solutions that work for the patients, citizens, employees, end users or customers. NNIT consists of group company NNIT A/S and subsidiaries SCALES, Excellis Health Solutions and SL Controls. Together, these companies employ more than 1,800 people in Europe, Asia, and USA.

We celebrate diversity and are committed to creating an inclusive environment for all employees. All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin colour, and ethnic origin.

In the interest of fostering a fair and unbiased recruitment process, we kindly request candidates to refrain from including their pictures in their applications.