Quality Assurance Specialist (Up to $8k) / Biopharma Manufacturing MNC #HLWJ

Quality Assurance Specialist (Up to $8k) / Biopharma Manufacturing MNC #HLWJ

Job Responsibilities:

Qualification/Validation Support:

• Assist in site projects related to qualification and validation.

Document Review & Approval:

• Review and approve documents for Quality Control (e.g., Analytical Instrument Qualification, Method Validation, Critical Reagent Qualification).
• Ensure compliance with internal procedures and regulatory requirements.
• Evaluate and approve discrepancies in qualification/validation protocols and document corrective actions.
• Act as Quality Representative for Quality Systems and Validation in projects.
• Provide validation expertise during development or modification phases of qualification activities.

Quality Oversight:

• Ensure documentation of qualification/validation is clear and defendable during inspections.
• Provide oversight for Quality Control validation maintenance and Master Validation Plan.

Multisite Coordination:

• Support harmonization of Quality Systems and validation activities across plants.
• Foster strong partnerships with other departments to ensure open communication.

EHS & Conduct:

• Adhere to Environmental, Health, and Safety (EHS) requirements.
• Maintain behavior in accordance with Shire’s Code of Conduct.

Requirements:

• Perform any additional tasks as assigned by Manager/Supervisor.
• Minimum Bachelor’s degree in any Science discipline.
• Additional certificates such as Certified Quality Engineer would be advantageous.
• Experience in biotechnology/pharmaceutical in QA/manufacturing operations preferred.
• Ability to work hands-on.
• Understanding of FDA/EU cGMP validation requirements and ICH guidelines.
• Critical thinking and problem-solving skills.

For interested candidates, please send your most recent and updated resume to temphc@recruitexpress.com.sg.