Computerized Systems & Data Integrity Junior Specialist

About the Role

This is not a typical IT role, nor is it solely a QA documentation role. We are looking for a person who wants to grow in the area where pharmaceutical manufacturing, computerized systems, GMP compliance, data integrity, and digital transformation meet. The role is suitable for both candidates with initial experience in CSV, GMP, IT systems, QA, QC, or production systems, as well as motivated graduates who are willing to learn. You will work with computerized systems used in GMP processes and support their validation, maintenance, administration, and continuous improvement. This role is a good opportunity for someone who wants to build a long-term career in pharma digitalization, CSV, data integrity, or GxP IT.

This role may be suitable for you if:

• You are interested in digital tools, data, or automation

• You like understanding how systems work, not only using them

• You are careful with details and understand that data must be reliable

• You are willing to learn GMP, Annex 11, computerized system validation, and ALCOA+ principles

• You enjoy working with different departments such as IT, QA, QC, Production, Engineering, and Warehouse

• You are not afraid of documentation, but you also want to work with real systems and real business processes

Key Responsibilities:

• Support computerized system validation activities, including URS, Risk Assessment, IQ/OQ/PQ and validation reports

• Assist in maintaining GMP computerized systems in a validated state

• Participate in system administration, user access review, periodic review, backup/recovery checks, and change control activities

• Ensure compliance with data integrity and ALCOA+ principles

• Work with IT, QA, QC, Production, Engineering, and other departments to support system compliance

• 0–2 years

Yêu cầu công việc

• 0–2 years of experience in CSV, IT systems, QA, QC, Production, Engineering, or GMP environment

• Fresh graduates are welcome if you are motivated and eager to learn

Skills and Mindset

• Experience or interest in Power BI, automation, AI, or data analysis

• Understanding of GMP, EU GMP Annex 11, CSV, or data integrity principles

• Basic knowledge of SQL (nice to have)

• Interest in digital transformation in pharmaceutical manufacturing

• English efficiency (daily work & communication within the team in English)

• Good attention to detail

• Logical thinking and willingness to investigate problems

What You Can Learn in This Role

• Computerized System Validation in a real GMP environment

• EU GMP Annex 11 and data integrity expectations

• How pharmaceutical systems are implemented, validated, maintained, and improved

• How to work across IT, Quality, Production, Warehouse, Engineering, and QC

• How digital systems support real manufacturing and quality processes

Quyền lợi

• Thưởng: Xem xét tăng lương định kỳ hàng năm
• Đào tạo: Thưởng tháng/ quý/ năm tuỳ theo vị trí công việc
• Khác: Thưởng lương tháng 13