Senior Specialist - Quality Assurance (Validation)

pharmagend global medical services pte. ltd.; Singapore; Presencial; SGD 90 000 - 130 000; Tempo integral

Resumo da oferta

pharmagend global medical services pte. ltd. in Singapore is hiring a Validation Specialist to lead qualification and validation activities in a regulated pharmaceutical manufacturing environment.

You will prepare and review URS, DQ/IQ/OQ/PQ, and coordinate with cross-functional teams to meet schedules while ensuring regulatory compliance. 5–7 years of relevant experience and proficiency with MS Word, Excel, Access, PowerPoint and Explorer are required; strong teamwork and problem-solving are

Qualificações

• Degree in a scientific discipline or equivalent.
• 5-7 years’ experience in pharmaceutical manufacturing.
• Experience in a regulated industry preferred.
• Proficient in MS Word, Excel, Access, PowerPoint, and Explorer.

Responsabilidades

• Prepare and review qualification documents (URS, DQ, IQ, OQ, PQ) per regulatory guidelines.
• Execute qualification and validation activities (process, cleaning, computer systems, equipment, utilities, facility).
• Lead qualification/validation knowledge and apply principles practically.
• Coordinate with cross-functional teams and external service providers to meet schedules.
• Review change controls; perform risk assessments on proposed changes.
• Write, review and revise validation SOPs per regulatory guidelines.
• QA oversight during validation processes.
• Manage incidents and deviations related to validation/qualification.
• Perform compliance reviews of deviations, investigations, CAPAs related to qualification/validation.
• Suggest improvements to Validation Master Plan and validation strategies.
• Cross train and develop expertise in other validation areas.
• Interact and lead effectively in a team-based environment.
• Familiarity with regulatory/compliance environment.

Conhecimentos

Quality assurance

Regulatory compliance

GxP experience

Formação académica

Bachelor's degree in a scientific discipline

Ferramentas

Microsoft Word

Microsoft Excel

Microsoft Access

PowerPoint

Internet Explorer

Descrição da oferta de emprego

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.

We regret that only shortlisted candidates will be contacted.