QA Specialist
1 day ago
Join to apply for the QA Specialist (Senior/ Associate Principal)role at Roche At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. As a QA Specialist in the Quality Systems and Compliance department, you are responsible for providing quality oversight and managing all related activities in line with Roche policies, standards, procedures, and Global cGMPs. Your functional duties include managing regulatory inspections and corporate GMP audits, managing the internal inspection readiness program, and overseeing the systematic evaluation of new and emerging regulations. You'll also be responsible for supplier management, trending quality compliance performance, and acting as a regulatory liaison by addressing queries from Health Authorities and internal partners. The Opportunity Audit and Inspection Management: Oversee regulatory inspections, internal and external audits, and manage the site's self-inspection program to drive continuous improvement Inspection Readiness: Develop and lead all site inspection readiness activities, including managing responses and mitigation plans for any observations Compliance Risk Management: Manage the compliance risk program, keeping the site informed about new requirements and emerging trends Supplier Quality: Support GxP supplier management and collaborate with the Global Supplier Quality team to maintain GxP agreements Regulatory Liaison: Act as a key liaison with PT Regulatory, coordinating between the site and PTR, and managing import and distribution licenses with affiliates Quality Systems Oversight: Manage the site's Quality Systems program to ensure it's effective, efficient, and compliant with all relevant regulations Risk Management: Oversee the risk management program to ensure potential product and patient risks are systematically assessed and documented Continuous Improvement: Ensure the continuous improvement of the Quality Management System (QMS) processes, including the Site Master File, MRoQ, Quality Risk Management, and APQR Who you are Education and Experience: A degree in Science or Engineering with a minimum of five years of relevant experience in a pharmaceutical setting Industry Knowledge: Strong understanding of Quality System principles, cGMP, and both local and international regulations, with a familiarity with Operations Audit and Compliance Expertise: Proven knowledge of audit or inspection management and a strong analytical ability to interpret and apply quality standards Leadership and Teamwork: A detail-oriented leader with excellent communication skills who can work both independently and collaboratively under pressure Professional Skills: Demonstrated ability to make sound decisions, manage priorities, and build strong relationships to drive results Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Roche is an Equal Opportunity Employer. #J-18808-Ljbffr
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Specialist, QA
4 weeks ago
Singapore Lonza Group Ltd. Full timeSpecialist, QA (Quality External) - Fixed Term Contract page is loadedSpecialist, QA (Quality External) - Fixed Term Contract Apply locations SG - Tuas, Singapore time type Full time posted on Posted 2 Days Ago job requisition id R69925Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no...
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Specialist, QA
4 weeks ago
Singapore Lonza Biologics Porriño SLU Full timeSpecialist, QA (CGT) - Fixed Term Contract Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...
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QA Specialist
1 week ago
Singapore ANTER CONSULTING PTE. LTD. Full timeAbout the Role We are hiring a QA Specialist for a leading pharmaceutical biologics client. This role offers an exciting opportunity to contribute to the assurance of quality standards in biologics manufacturing. The ideal candidate will bring 3+ years of experience in pharmaceutical quality assurance, with a strong emphasis on GMP compliance, batch record...
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Specialist, QA
4 weeks ago
Singapore Lonza Biologics Porriño SLU Full timeSpecialist, QA (Quality External) - Fixed Term Contract Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people...
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QA Specialist
1 week ago
Singapore GMP Group Full time**QA Specialist** Our client is the renowned manufacturer and supplier of medical & healthcare products in Singapore. They are committed to enhance the quality of life through constant product innovation and quality enhancement. Join them to take pride of what you can do to improve people’s life. *** **Responsibilities**: - To prepare and update all...
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QA Specialist
4 weeks ago
Singapore Pfizer Full timeQA Specialist (Compliance) (PCP) 15 months training programme page is loadedQA Specialist (Compliance) (PCP) 15 months training programme Solliciteren locations Singapore - Tuas time type Voltijds posted on Vandaag geplaatst job requisition id Job DescriptionCareer Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing...
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QA Specialist
4 weeks ago
Singapore Pfizer Full timeQA Specialist (Compliance) (PCP) 15 months training programme page is loadedQA Specialist (Compliance) (PCP) 15 months training programme Apply locations Singapore - Tuas time type Full time posted on Posted Today job requisition id Job DescriptionCareer Progression Program (CCP) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals We...
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QA Specialist Trainee
4 weeks ago
Singapore Roche Full timeQA Specialist Trainee - Train and Place Program Join to apply for the QA Specialist Trainee - Train and Place Program role at Roche . At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you...
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Singapore Wargaming Full timeAs a dedicated Localization QA Specialist, you will participate in the localization of game client and content for Wargaming.net. Reports to Head of Localization&QA/Customer Support, APAC What will you do?Tests game localization; assesses product design, quality, and reliability Review and fine-tune the translated text by verifying the integrity of the text...
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Specialist, QA
3 days ago
Singapore Lonza Biologics Porriño SLU Full timeSpecialist, QA (CGT) - Fixed Term Contract Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...
