Validation Specialist

17 hours ago


Singapore RECRUIT EXPRESS PTE LTD Full time
Job Summary

A highly skilled Validation Specialist is needed to join our team at Recruit Express Pte Ltd. The successful candidate will be responsible for ensuring the validation and qualification of equipment, processes, and facilities in a cGMP manufacturing environment. This role requires a strong understanding of quality regulations and standards, including FDA, EU, ISO, ICH, and ISPE guidelines.

Key Responsibilities

* Develop and implement validation plans for new equipment, processes, and facilities
* Conduct facility and equipment qualification activities, including IQ/OQ and PQ
* Review and analyze data generated from validation activities
* Author validation reports and ensure compliance with regulatory requirements
* Collaborate with cross-functional teams to ensure quality and regulatory compliance

Requirements

* 5+ years of experience in a regulated environment
* Strong knowledge of quality regulations and standards
* Excellent analytical and problem-solving skills
* Ability to work independently and as part of a team
* Bachelor's degree in an Engineering discipline or Life Science

Preferred Qualifications

* 3-5 years of experience in a cGMP pharmaceutical setting
* Experience with facility, equipment, and cleaning validation
* Knowledge of clean room standards and processing equipment used to manufacture APIs

About Us

Recruit Express Pte Ltd is a leading healthcare and lifesciences recruitment agency. We are committed to providing high-quality recruitment services to our clients and candidates.

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