Education and Experience- Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree is a plus
Experience in Pharmaceutical or related industry- Has a good understanding of quality management systems and has participated in local or international audits as an auditee, auditor or trainer. Familiarity with ISO9001 a plus.
Support all aspects of the validation life cycle from design through operation, improvement and retirement.- Develop, review and manage project lifecycle documentation with support from experienced validation experts, including Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Validation Deviations and Qualification Reports with relevant stakeholders.
Coordinate with relevant stakeholders to execute and close validation protocols and procedures to ensure systems meet with appropriate regulatory agency validation requirements, clients requirement and current company standards.
- Inspect completed work and/or work in progress at sites to ensure conformity of material and works according to specifications and requirements.
Assist in deviation investigation, resolution of problems and issues encountered during field execution activities.- Interfacing with customers to develop validation documentation, schedule and communicate results.
Generation, maintenance, and technical review of standard operational procedures for validation activities.
- Assists in developing validation strategies and training internal personnel on validation method, policies and procedures.
Job Type: Full-time
Pay: RM3,
- 00 - RM4,500.00 per month
Benefits: - Health insurance
Maternity leaveSchedule:Supplemental pay types:
Overtime pay
