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Validation Executive
1 week ago
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, client's 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.
Pay:
RM3, RM4,500.00 per month
Benefits:
- Health insurance
- Maternity leave
- Parental leave
Schedule:
- Monday to Friday
Supplemental pay types:
- Overtime pay
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