Validation Specialist HAINA

Validation Specialist

Responsible for assuring that computerized systems with GxP impact meet user requirements and are in compliance with applicable standards, policies, specifications, and procedures.

Qualification and Experience Required:

·         BS degree in computer science, industrial engineering, life science or related field degree and 3 or more years of experience in medical device or pharmaceutical industry.

·         Familiarized with System Development Life Cycle and Software Quality Assurance.

·         Experience working with Electronic Records and Electronic Signature concepts.

·         Ability to handle priorities and multiple projects at the same time.

• Good written and verbal communication, presentation, organizational and teamwork skills with strong desire and ability to deliver results
• Ability to quantify the fundamental risks and problems associated with the implementation, technology changes, and on-going life cycle of GxP computerized systems.
• Good interpersonal, verbal and written communications, time management, and organizational skills
• Leadership, results-oriented, and teamwork.
• Attention to detail and commitment to accuracy and quality.
• Knowledge of FDA Quality System Regulations and requirements of ISO 9000, ISO 13485 and Medical Device Directive, Canadian Medical Device Regulation.
• Knowledge of FDA's CFR 21 Part 11 validation requirements as applied to Life Sciences companies.

·         Intermediate to advance English level.

How to apply???

Send me your resume to: Kat.genao@gmail.com or Katherine.genao@fresenius-kabi.com