- Singapore
全职 QA Operation 工作, 薪水 up to SGD 6,000, NUSANTARA PRIME CONSULTING PTE. LTD. 公司招聘中 - Ricebowl
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职位描述
岗位职责
Responsible for overseeing manufacturing, testing and validation activities, ensuring compliance with internal procedures and regulatory requirements.
Responsibilities:
Oversee routine quality control for on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.
Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained
Accountable for QA Review of all Qualification and Validation protocols and reports, including computer system validation.
Ensures that the data integrity of all documentation and electronic data complies to all application regulations and SOP requirements
Participate in site operational readiness programs, including self-inspection and data integrity surveillance for GMP and client audits.
Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
Carry out additional tasks as assigned by leadership.
About You:
Bachelor’s degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
At least 1-3 years of relevant QA experience in Biopharma or Pharmaceuticals for Junior role & 3-5 years of experience for Senior role.
Familiar with FDA, EMEA, and PICS GMP requirements.
Knowledgeable in biological product manufacturing and related quality control requirements.
Experience in biopharma commercial supply is preferred.
Experience with a new site start-up is preferred.
Proficient in English listening, speaking, reading, and writing.
Skilled in Microsoft Word, Excel, PowerPoint, etc.
Strong learning ability.
Excellent cross-functional communication and collaboration skills.
Strong logical thinking and conflict management abilities.
Demonstrates strong ownership.
Contract Period: 12 months
Nusantara Prime Consulting Pte. Ltd (NPC)
is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.
Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.
Our Mission
With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.
Our Vision
To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.
Responsibilities:
Oversee routine quality control for on-site GMP production and testing, ensuring all GMP activities are executed in strict adherence to company procedures.
Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
Provide quality oversight for validation and re-qualification activities, ensuring validation status is consistently maintained
Accountable for QA Review of all Qualification and Validation protocols and reports, including computer system validation.
Ensures that the data integrity of all documentation and electronic data complies to all application regulations and SOP requirements
Participate in site operational readiness programs, including self-inspection and data integrity surveillance for GMP and client audits.
Manage quality events, including deviations, change controls, CAPA, and lab investigations etc.
Carry out additional tasks as assigned by leadership.
About You:
Bachelor’s degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
At least 1-3 years of relevant QA experience in Biopharma or Pharmaceuticals for Junior role & 3-5 years of experience for Senior role.
Familiar with FDA, EMEA, and PICS GMP requirements.
Knowledgeable in biological product manufacturing and related quality control requirements.
Experience in biopharma commercial supply is preferred.
Experience with a new site start-up is preferred.
Proficient in English listening, speaking, reading, and writing.
Skilled in Microsoft Word, Excel, PowerPoint, etc.
Strong learning ability.
Excellent cross-functional communication and collaboration skills.
Strong logical thinking and conflict management abilities.
Demonstrates strong ownership.
Contract Period: 12 months
Nusantara Prime Consulting Pte. Ltd (NPC)
is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.
Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.
Our Mission
With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.
Our Vision
To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.
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