Key responsibilities:
• Monitor day-to-day Validation activities in accordance with approved SOPs / Plan / Policies for a small scale, multi-product, GMP biotech contract development/manufacturing facility
• Participate in review and approval of Validation Protocols / Reports including site discrepancies and deviations investigation / closure
• Support / participate in validation activities during facility startup / shutdown / changeover and routine GMP operations
• Support / participate in Site Validation Maintenance Program and implementation of department training requirements
• Develop Validation Plans for a change implementation project as required
• Active co-ordination with internal and external validation resources to achieve department / project goals
• Liaise with system owners, quality unit and other relevant departments to ensure scope, execution and reporting of Site Validation Program meet expectations
• Review & assess Site Change Controls, implementation of Validation CAPAs and subsequent closure
• Participate in Customer / Agency Audits and Inspections as required
• Participate in on-job training program for staff
• Any other tasks as and when assigned by supervisor


Key requirements:
• 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 leadership skills
• Strong interpersonal skills
• Effective Communicator (oral and written)
• Exhibit good quality decision making traits
• Meticulous and Systematic
• Analytical Mind
• Ability to define specific goals clearly, to develop and prioritize activities
• Team player, with strong focus on safety, quality and timelines

联系地址：广东省广州市黄埔区九佛建设路1039号　

联 系 人：饶小姐