COMBUILDER PTE LTD
Responsibilities:
To execute Computerized Systems Validation (CSV) activities, including planning, testing, documentation, and reporting.
To assess the qualification of GMP-related Computerized Systems such as
PCS 7 ,
EMS ,
MES , and other automated systems. To work closely with the Compliance Engineering team to support commissioning, qualification, and validation (CQV) activities. To prepare, review, and approve qualification documentation (URS, DQ, FAT, SAT, IOQ, Summary Reports) in accordance with
GAMP 5 ,
GDP , and
21 CFR Part 11 . Ensure validation strategies are aligned with internal quality standards and regulatory guidelines. Investigate and document deviations, ensuring timely closure with root cause analysis and corrective/preventive actions (CAPA). Maintain change control records and ensure appropriate validation impact assessments. Maintain up-to-date knowledge of evolving
GxP
and regulatory requirements to ensure continued compliance and process improvements. Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports) Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements. Investigate deviations and write deviation reports and findings. Raise and follow-up change control records. Requirements: Degree in Computer Science, Engineering, Science or related studies. At least 4 years’ experience in Computerized Systems Validation (CSV) in a
GxP-regulated environment . Must have good track record in developing Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities. Good knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle and Good Documentation Practices (GDP) Good understanding in Regulatory compliance. Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply. Certified or highly skilled in Six Sigma
methodology. Strong proficiency in
SAP
and other enterprise systems. Familiarity with tools like
Trackwise ,
Kneat , or similar validation/documentation platforms. Previous experience supporting both clinical and commercial manufacturing environments is a plus. (Preferred) Applicant with training or certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS.
#J-18808-Ljbffr
PCS 7 ,
EMS ,
MES , and other automated systems. To work closely with the Compliance Engineering team to support commissioning, qualification, and validation (CQV) activities. To prepare, review, and approve qualification documentation (URS, DQ, FAT, SAT, IOQ, Summary Reports) in accordance with
GAMP 5 ,
GDP , and
21 CFR Part 11 . Ensure validation strategies are aligned with internal quality standards and regulatory guidelines. Investigate and document deviations, ensuring timely closure with root cause analysis and corrective/preventive actions (CAPA). Maintain change control records and ensure appropriate validation impact assessments. Maintain up-to-date knowledge of evolving
GxP
and regulatory requirements to ensure continued compliance and process improvements. Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports) Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements. Investigate deviations and write deviation reports and findings. Raise and follow-up change control records. Requirements: Degree in Computer Science, Engineering, Science or related studies. At least 4 years’ experience in Computerized Systems Validation (CSV) in a
GxP-regulated environment . Must have good track record in developing Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities. Good knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle and Good Documentation Practices (GDP) Good understanding in Regulatory compliance. Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply. Certified or highly skilled in Six Sigma
methodology. Strong proficiency in
SAP
and other enterprise systems. Familiarity with tools like
Trackwise ,
Kneat , or similar validation/documentation platforms. Previous experience supporting both clinical and commercial manufacturing environments is a plus. (Preferred) Applicant with training or certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS.
#J-18808-Ljbffr