QA Specialist (Validation)

Pharmagend Global Medical Services Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading healthcare company in Singapore is seeking a qualified professional to manage validation and qualification duties. Responsibilities include preparation and review of qualification documents, execution of validation activities, and managing incidents related to validation. Candidates should hold a degree in a scientific discipline and have 5-7 years of experience in a pharmaceutical manufacturing environment. Familiarity with regulatory compliance is a must.

Qualifications

• Experience in a regulated industry is preferred.
• Minimum 5-7 years' experience in pharmaceutical manufacturing.

Responsibilities

• Preparation and review of qualification documents.
• Execution of qualification and validation activities.
• Manage incidents and deviations related to validation.

Skills

Knowledge of qualification/validation principles

Ability to interact and lead in teams

Education

Degree in scientific discipline or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Microsoft PowerPoint

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

We regret that only shortlisted candidates will be contacted.