Salary not disclosed by employer
Job Description
Job description:
• Develop, review and approval of Validation Lifecycle Document, Validation Protocols and Reports including supporting discrepancies and deviations investigation / closure in line with RSTO policies and standards.
• Ensure that all validation activities with respect to equipment/facility qualification and cleaning validation stated in validation plan/ protocol are carried out in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion.
• Perform IQ, OQ and PQ of classified areas or equipment eg Biosafety cabinets, ISO 5 rooms.
• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Any other tasks as and when assigned by Supervisor.
• Engineering/Science Degree or higher from recognized institution
• Minimum 5 years of experience in Validation in the pharmaceutical/biotech industry or equivalent holders with combination of education and relative work experience
• Familiarity with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, GAMP and ICHQ7).
• Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility
• Good oral and written communication skills
• Meticulous and Systematic
• Ability to adapt to rapidly changing priorities and the flexibility to support operations in accordance with the manufacturing schedule.
• Must be highly motivated, able to work independently as well as a Team player, with strong focus on safety, quality and timeline.