About Our Client

Our client is a multi-disciplined business consultancy, dedicated to providing valuable technical and digital transformation services across various industries. They are committed to helping clients navigate the complexities of a rapidly changing market and supply chain landscape.

What you'll be doing?

• Equipment qualification: Ensure that temperature-controlled units, laboratory equipment, and manufacturing support systems are installed, tested, and qualified in compliance with cGMP and regulatory requirements.
• Documentation creation: Draft critical qualification deliverables such as URS, risk assessments, and CQ protocols, contributing to the overall quality assurance process.
• Vendor oversight: Review equipment vendor's IOQ documents and support them in conducting equipment CQ, calibration, and maintenance activities.
• Hands-on execution: Perform and document qualification activities, ensuring all systems meet project-specific standards and regulatory requirements.
• SOP development: Create, revise, and review standard operating procedures and related operational documents, enhancing overall efficiency and compliance.

Who are they looking for?

• Educational background: Candidates with a Bachelor's degree in Life Sciences, Engineering, or a related field, bringing a strong foundation in technical knowledge.
• Industry exposure: At least 2 years of experience in pharmaceutical, medical device, or related environments, familiar with industry best practices and regulations.
• Operational know-how: Professionals with working experience in manufacturing or laboratory operations and equipment, capable of applying practical knowledge to qualification processes.
• Regulatory awareness: Understand computerized system requirements in the pharmaceutical industry, such as 21 CFR Part 11 and Annex 11, ensuring compliance in all activities.
• VLMS proficiency: Candidates with experience using Validation Lifecycle Management Systems like Kneat or Valgenesis is a must.

Other Information:

• Working Day: Monday to Friday, 8am-5pm
• Location: West, Tuas
• Salary: $5500 - $7500

Jobs DB Singapore Pte Ltd | 24C2640
Low Jia Yi | R25127265
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