Senior Validation Specialist

2 days ago


Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time

Job Summary

We are seeking an experienced Senior Validation Specialist to join our team at PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD.

About the Role

The ideal candidate will have a strong background in validation and quality assurance, with a minimum of 5-7 years' experience in pharmaceutical manufacturing environments.

Key Responsibilities

  • Develop and implement qualification and validation protocols for equipment, systems, and processes in compliance with regulatory guidelines.
  • Lead cross-functional teams to execute qualification and validation activities, including process, cleaning, computer system, equipment, utilities, and facility.
  • Candidate must have knowledge and experience of qualification/validation principles and their practical application.
  • Prepare and review process and cleaning validation protocols and reports.
  • Coordinate with external service providers to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.
  • Review equipment and process-related change control; perform Risk Assessment to determine criticality of the proposed changes.
  • Write, review, and revise validation SOPs in compliance with regulatory guidelines.
  • QA oversight and/or review during the validation process.
  • Manage incidents and deviations related to validation & qualification.
  • Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.
  • Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.
  • Cross-train and develop expertise in other areas of validation.
  • Must be able to interact and lead effectively in a team-based environment.
  • Familiarity with regulatory/compliance environment.

Requirements

  • Bachelor's degree in a scientific discipline or equivalent.
  • A minimum of 5-7 years' relevant experience in pharmaceutical manufacturing environments.
  • Proficient in the use of Microsoft Office applications (Word, Excel, Access, PowerPoint).

Salary and Benefits

The estimated salary for this role is SGD 80,000 - 120,000 per annum, depending on experience.

In addition to a competitive salary, we offer a comprehensive benefits package, including medical insurance, retirement plan, and annual leave.

Why Join Us?

At PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD., we value our employees' skills and contributions. We offer opportunities for professional growth and development, as well as a dynamic and supportive work environment.



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