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Title

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Validation Officer

Description

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We are looking for a meticulous Validation Officer to ensure that our processes and systems comply with internal and external regulations. The Validation Officer will be responsible for planning, implementing, and monitoring the validation strategy in highly regulated industries such as pharmaceuticals, biotechnology, and medical devices. The successful candidate will be able to understand and interpret regulations, develop validation schedules, write and review validation protocols, and maintain an awareness of advances in the field. This role requires a high level of attention to detail, excellent problem-solving skills, and a strong understanding of validation principles and guidelines.

Responsibilities

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  • Develop and implement validation procedures.
  • Coordinate with various departments to ensure compliance with validation regulations.
  • Review and approve validation protocols and reports.
  • Identify and resolve validation issues.
  • Maintain validation documentation and records.
  • Conduct validation training for staff.
  • Monitor changes in regulations and implement necessary changes.
  • Participate in audits and inspections.
  • Ensure all systems are operating according to necessary specifications.
  • Maintain knowledge of advancements in the field of validation.

Requirements

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  • Bachelor's degree in a related field.
  • Experience in a regulated industry.
  • Strong understanding of validation principles and guidelines.
  • Excellent problem-solving skills.
  • High level of attention to detail.
  • Ability to interpret and understand regulations.
  • Strong written and verbal communication skills.
  • Ability to work independently and as part of a team.
  • Proficiency in Microsoft Office Suite.
  • Experience with validation software.

Potential interview questions

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  • Can you describe your experience with validation in a regulated industry?
  • How do you ensure compliance with validation regulations?
  • Can you describe a time when you identified and resolved a validation issue?
  • How do you maintain your knowledge of advancements in the field of validation?
  • Can you describe your experience with validation software?