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Computer System Validation (CSV) Consultant Job Opening In Malaysia – Now Hiring Arcondis Group


Job description

Overview

We are looking for an experienced Consultant in Computer System Validation and IT Compliance to lead CSV efforts for our life sciences client.

We are hiring dedicated resources to work on a specific client account, where you’ll be involved in ongoing projects and support activities that are critical to the client’s success.

This is not just a project-based role — it’s a chance to build deep domain expertise, long-term collaboration, and a meaningful career path.

You will ensure compliance with regulations like 21 CFR Part 11 and Part 820 by developing lifecycle documentation, test protocols, and reviewing technical documentation.

Collaborating with customers’ IT, Quality, and Regulatory teams (QA eCompliance, Data Privacy), you will validate both new and existing systems while leveraging best practices in CSV, automation testing, and methodologies such as DevOps, Agile, Scrum, Waterfall, and ITIL.

Note: We are seeking candidates who are currently based in Malaysia and possess a valid work visa.

Kindly be aware that we do not offer visa assistance for applicants residing outside the Malaysia region.

Key Responsibilities

  • Lead and oversee computer system validation (CSV) efforts for life sciences clients, ensuring adherence to regulatory requirements such as 21 CFR Part 11 and 21 CFR Part 820, but not limited.

  • Develop and implement comprehensive lifecycle documentation for GxP relevant computer systems, including the creation and execution of test protocols.

  • Review technical documentation and support IT compliance strategies to maintain the security, reliability, and regulatory compliance of computer systems.

  • Collaborate with cross-functional teams, including IT, Quality, and Regulatory, to design and execute validation plans for both new and existing computer systems and digital initiatives.

  • Provide expert guidance and support on CSV and automation testing, ensuring best practices and regulatory compliance.

  • Experienced in DevOps, Agile, Scrum, Waterfall, and ITIL methodologies, with a strong understanding of industry best practices.

Qualifications, Skills and Experience

  • Bachelor’s or master’s degree in computer science, Engineering, Pharmaceuticals, or a related field.

  • Minimum of 4 years of experience in computer system validation (CSV), hardware qualification, IT compliance, testing automation, or related disciplines.

  • In-depth knowledge of relevant regulations and industry best practices, including FDA regulations, EudraLex and GAMP5.

  • Proven ability to lead and manage multiple CSV projects and digital initiatives, including documentation development, testing efforts, and compliance assurance.

  • Experience with testing automation tools, process-controlled systems, application lifecycle management tools and paper-based testing
  • Strong communication skills with the ability to work effectively with cross-functional teams
  • Expertise in cloud-based solutions, SAP, Clinical Trial Management Systems (CTMS), Veeva Vault, Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), electronic Lab Notebooks (eLN), change management, deviation and CAPA processes, as well as experience with AI/ML, automation, and Robotic Process Automation (RPA) is a plus.

  • Strong facilitation skills with excellent organizational and interpersonal abilities.

  • Willingness to continuously improve and grow with new challenges

Why Arcondis

  • An opportunity to shape the future of healthcare by spearheading transformative deals
  • A collaborative and innovative work environment, where your ideas are valued, and your contributions make a significant impact
  • Flexible working environment, enabling work-life balance
  • Attractive compensation package, inclusive of performance-based incentives that reward exceptional achievements
  • Professional growth and development opportunities

Seniority level

  • Mid-Senior level

Employment type

  • Full-time

Job function

  • Consulting
  • Industries
  • Pharmaceutical Manufacturing

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Required Skill Profession

Consulting


  • Job Details

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Unlock Your Computer System Potential: Insight & Career Growth Guide


Real-time Computer System Jobs Trends (Graphical Representation)

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Great news! is currently hiring and seeking a Computer System Validation (CSV) Consultant to join their team. Feel free to download the job details.

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The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Arcondis Group adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying Malaysia laws and regulations

What Is the Average Salary Range for Computer System Validation (CSV) Consultant Positions?

The average salary range for a varies, but the pay scale is rated "Standard" in Malaysia. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

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Key qualifications for Computer System Validation (CSV) Consultant typically include Consulting and a list of qualifications and expertise as mentioned in the job specification. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

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Interview Tips for Computer System Validation (CSV) Consultant Job Success

Arcondis Group interview tips for Computer System Validation (CSV) Consultant

Here are some tips to help you prepare for and ace your Computer System Validation (CSV) Consultant job interview:

Before the Interview:

Research: Learn about the Arcondis Group's mission, values, products, and the specific job requirements and get further information about

Other Openings

Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

Dress Professionally: Choose attire appropriate for the company culture.

Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

During the Interview:

Be Punctual: Arrive on time to demonstrate professionalism and respect.

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Final Thought:

To prepare for your Computer System Validation (CSV) Consultant interview at Arcondis Group, research the company, understand the job requirements, and practice common interview questions.

Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Arcondis Group's products or services and be prepared to discuss how you can contribute to their success.

By following these tips, you can increase your chances of making a positive impression and landing the job!

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