QA Specialist (Validation)

Pharmagend Global Medical Services Pte Ltd; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Singapore is seeking a Validation Specialist to oversee qualification and validation processes. The ideal candidate should have 5-7 years of relevant experience in a regulated pharmaceutical environment and a degree in a scientific discipline. Responsibilities include document preparation, managing validation incidents, and ensuring compliance with regulatory standards. This position requires strong leadership skills in a team-based environment with proficiency in Microsoft Office.

Qualifications

• Minimum 5-7 years of relevant experience in a pharmaceutical manufacturing environment.
• Familiarity with regulatory compliance.
• Experience in a regulated industry preferred.

Responsibilities

• Preparation and review of qualification documents in compliance with regulatory guidelines.
• Execution of qualification and validation activities.
• Manage incidents and deviations related to validation and qualification.

Skills

Knowledge of qualification/validation principles

Experience with regulatory compliance

Leadership in a team-based environment

Proficient in Microsoft Office Suite

Education

Degree in a scientific discipline or equivalent

Job description

KEY DUTIES AND RESPONSIBILITES:

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.
• Execution of 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.
• Preparation and review of process and cleaning validation protocols and reports.
• Coordinate with the cross functional team and external service provider 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.

EDUCATION & EXPERIENCE

• Degree a scientific discipline or equivalent.
• Experience in a regulated industry preferred.
• A minimum of 5-7 years’ relevant experience in pharmaceutical manufacturing environment.
• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.

TO APPLY

Candidates are encouraged to apply this position via email to [e-mail] with the following information in the resume.

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.