Quality Specialist (Contract) | Pharma Biotech #HJO

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical sector is looking for a Quality Assurance Specialist to support validation projects and ensure compliance with industry standards. This role involves document review, training, and collaboration across various sites to standardize validation processes. The ideal candidate should possess a Bachelor’s degree in a relevant field and have 2-3 years of experience in validation or quality assurance.

Qualifications

• Bachelor’s degree in a relevant field required.
• 2-3 years of experience in quality assurance or validation.
• Strong understanding of FDA/EU cGMP requirements.

Responsibilities

• Support validation projects and ensure compliance.
• Review and approve validation documents.
• Train and coach team members.

Skills

Problem Solving

Compliance

Attention to Detail

Collaboration

Education

Bachelor’s degree in Pharmaceutical Sciences

Life Sciences, Biology, Biotechnology, Chemistry, Chemical Engineering

Job description

Job Scope

• Support Validation Projects: Assist with qualification and validation activities, ensuring compliance with company procedures and regulations.
• Review and Approve Documents: Review and approve validation documents like protocols, reports, and procedures.
• Manage Discrepancies: Identify and address issues in validation protocols, ensuring corrective actions are documented.
• Act as Quality Representative: Participate in cross-functional projects as the Quality Systems and Validation representative.
• Provide Validation Expertise: Offer guidance on creating or updating validation documents, such as for analytical instruments and methods.
• Ensure Document Readiness: Ensure all qualification/validation documents are clear and inspection-ready.
• Support Ongoing Validation: Oversee the Master Validation Plan and support routine qualification activities.
• Collaborate Across Sites: Help standardize validation processes across multiple sites.
• Train and Coach: Develop training materials and provide support to team members and other departments.

Job Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Biology, Biotechnology, Chemistry, Chemical Engineering, Engineering, or related field.
• At least 2-3 years of experience in quality assurance, manufacturing operations, or validation in the pharmaceutical or biotechnology industry. Experience in equipment, process, cleaning, and computer systems validation is preferred.
• Strong understanding of FDA/EU cGMP requirements, including CFR 21 Part 11, and familiarity with PDA and ISPE GAMP guidelines.

Interested candidates are invited to email your resume to:

[e-mail]

Jenalyn Ooi Huai Sian (R1765551)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

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