Validation Consultant

Major Responsibilities

▫ Participate in revenue generation initiatives through promotion of value added products and services, validation process, while developing and strengthening customer and market relationships that result in customer loyalty and positive referrals.

▫ Create a strategy that can deliver well and define the service support(eq. validation support) we need to provide to the customer in locally.

▫ Provide validation consulting and support to customer as requested, compliance to regulatory requirements and internal procedures are achieved.

▫ Assures validation documentation is generated, develops, reviews and leads the execution of Validation Plans and activities in accordance with documented procedures. If needed, suggests best practice for validation to customer and regulatory.

▫ Support customer audit initiatives related to validation activities and provide good practice in relatives.

▫ Support system management procedure discussion and troubleshooting support according to routine monitoring or validation management cycle

▫ Collaboration with Quality, IT and validation team in customer site

▫ Coordinate and provide consulting, technical training and on-going support and project

▫ Provide consistent follow up to ensure customer satisfaction and meet KPI

▫ Develop & retain business, strengthen customer relationship

▫ Act as a technical pillar for sub/clusters

▫ Recognized expertise on the market, ability to interact with KOL

Qualifications

▫ Bachelor’s degree in biology/microbiology/molecular or related

▫ 7-10 years’ experience in in GMP site and QA team(supervisor or senior level is preferred)

▫ Leading experience in regulatory inspection or audit in pharmaceutical regulatory bodies(MFDS, cGMP, FDA, EUGMP etc) is preferred

▫ Expert level for GMP, cGMP, USP, EP etc regulation KB

▫ Experience in RMM(rapid microbial method) solution is preferred

▫ Key contributor for service offer and deployment with clear understanding of the workflow at customer lab, having a broader vision of the solution proposed to the lab.

▫ Training and coaching capabilities

▫ Good communication skill with related department and employee and able to communicate his /her ideas clearly

▫ No limitation for local and international business trip

▫ Driving license

▫ Fluent English is preferred