Quality Specialist (Validation)

Bard Sdn Bhd; Kulim; On-site; MYR 70,000 - 100,000; Full time

Job summary

Bard Sdn Bhd in Malaysia is seeking a Validation Planning & Execution specialist for the eDHR project to develop and execute validation protocols (IQ/OQ/PQ) for systems and equipment. You will ensure compliance with FDA 21 CFR Part 11 and ISO 13485, perform performance testing, document results, and support QA with cross-functional validation activities across IT, OT, and manufacturing teams.

The role emphasizes data integrity, traceability, and rigorous documentation, including SOPs and reports

Qualifications

• Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology.
• Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments.
• Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.
• Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
• Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance.
• Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.
• Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems.
• Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports.
• Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications.
• Experience preparing regulatory submission documents and internal review reports.

Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
• Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
• Conduct performance testing and document results to confirm system functionality and reliability.
• Ensure eDHR systems comply with internal quality standards and external regulations.
• Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.
• Participate in audits and provide documentation to support compliance.
• Validate that eDHR systems accurately capture and store production data in real-time.
• Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.
• Ensure traceability and error-proofing mechanisms are functioning as intended.
• Author and maintain validation documentation, including protocols, reports, and SOPs.
• Record and analyze test data to identify anomalies and ensure systems meet specifications.
• Prepare detailed reports for internal review and regulatory submissions.
• Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.
• Support changing control processes and ensure validated state is maintained during updates.
• Train and mentor team members on validation procedures and compliance requirements

Job description

Validation Planning & Execution (eDHR project)

Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.

Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.

Conduct performance testing and document results to confirm system functionality and reliability.

System Compliance & Quality Assurance

Ensure eDHR systems comply with internal quality standards and external regulations.

Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.

Participate in audits and provide documentation to support compliance.

Process & Data Integrity

Validate that eDHR systems accurately capture and store production data in real-time.

Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.

Ensure traceability and error-proofing mechanisms are functioning as intended.

Documentation & Reporting

Author and maintain validation documentation, including protocols, reports, and SOPs.

Record and analyze test data to identify anomalies and ensure systems meet specifications.

Prepare detailed reports for internal review and regulatory submissions.

Cross-Functional Collaboration

Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.

Support changing control processes and ensure validated state is maintained during updates.

Train and mentor team members on validation procedures and compliance requirements

Qualifications:

Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology.

Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments.

Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.

Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.

Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance.

Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.

Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems.

Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports.

Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications.

Experience preparing regulatory submission documents and internal review reports.

Cross-Functional Collaboration

Collaboration skills to work with IT, OT, Manufacturing, and Quality teams.

Experience supporting change control processes and maintaining validated states during system updates

Unlock job insights

Hirer responsiveness Salary match Number of applicants

Your application will include the following questions:

• Which of the following statements best describes your right to work in Malaysia?

Pharmaceuticals, Biotechnology & Medical Devices 1,001-5,000 employees

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.

Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

BD partners with organizations around the world to address some of the most challenging global health issues. Our nearly 50,000 associates across 50 countries closely collaborate with customers and partners to help enhance patient outcomes, lower healthcare delivery costs, increase operational efficiencies and expand access to healthcare.

Our state-of-the-art facilities around the globe provide an environment that enables our highly talented and passionate workforce to be the best at their professions. We are always seeking great people to join our company on its journey to greatness.

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