Regulatory Compliance and Quality Assurance Professional
5 days ago
In this role, you will work closely with site management to foster a culture of quality, providing guidance on GMP principles and their application. You will also be responsible for mentoring peers towards achieving organizational and individual goals.
Responsibilities:- Collaborate with site management to ensure quality systems support cGMP manufacturing of pre-clinical to commercial products.
- Execute audit strategy and lead process audits to ensure regulatory compliance.
- Monitor quality to maintain inspection readiness and provide support during regulatory inspections or customer audits as requested.
You will have the opportunity to work on complex problems requiring in-depth evaluation of various factors from many sources. Interpretation of GMP regulations is essential in resolving problems and designing systems, processes, or procedures.
-
Regulatory Compliance Officer
2 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Overview:Fujifilm Diosynth Biotechnologies is seeking a highly skilled Quality Assurance-Compliance Specialist II-Audit and Inspection to join our team. This role will support all associated responsibilities in compliance with quality policies and site SOPs to ensure regulatory compliance.\About the Role:This position will work collaboratively with site...
-
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeThe Quality Assurance - Compliance Specialist II - Audit and Inspection plays a critical role in ensuring regulatory compliance across the organization. This professional collaborates with site management to instill a culture of quality, providing coaching on GMP principles and their underlying rationales. They also mentor peers towards achieving...
-
Quality Assurance Manager
6 days ago
Hamilton, Waikato, New Zealand Sealed Air Full timeAt Sealed Air, we are committed to excellence in safety, quality, and continuous improvement. As a Quality Assurance Manager, you will play a key leadership role in driving a strong safety culture, enhancing training programs, and ensuring compliance across our Hamilton site. Your primary responsibilities include:Responsibilities:Developing and implementing...
-
Quality Assurance Leader
4 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Quality Assurance (QA) Operations Supervisor will be responsible for overseeing the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with Fujifilm quality policies and site Standard Operating Procedures (SOPs) to ensure regulatory compliance.Reports to: Senior Manager, Quality...
-
Quality Assurance Specialist
2 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Summary:Fujifilm Diosynth Biotechnologies seeks a Quality Assurance-Compliance Specialist II-Audit and Inspection to support all associated responsibilities in compliance with quality policies and site SOPs to ensure regulatory compliance.\About Fujifilm Diosynth Biotechnologies:We are a global leader in the development and manufacturing of...
-
Quality Assurance Compliance Coordinator
4 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThis position plays a key role in ensuring compliance with regulatory requirements in the manufacturing process.Main ResponsibilitiesEnsure required Management and Quality approvals on final investigations while satisfying established due dates.Facilitate corrective and preventive action agreement with stakeholders.Support client due...
-
Regulatory Compliance Expert
2 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob SummaryThe Senior Quality Assurance (QA) Analyst will be responsible for ensuring the quality of our products by reviewing and approving basic and technical documentation, drafting and reviewing internal Quality policies and procedures, performing product-related activities, conducting Quality audits, and identifying process and Quality System...
-
Quality Assurance Specialist
3 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob SummaryWe are seeking a skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality and compliance of our products in accordance with regulatory requirements.Main Responsibilities:Review and approve documentation, including Standard Operating Procedures, Batch Production Records, and...
-
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition OverviewThe Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are...
-
Quality Assurance Specialist II
3 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob DescriptionThe Auditing and Compliance Specialist II plays a vital role in ensuring FUJIFILM Diosynth Biotechnologies' products meet regulatory requirements and industry standards.This position works collaboratively with site management to instill a 'Quality Culture,' mentoring peers toward achieving organizational and individual...
-
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timePosition OverviewThe Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are...
-
Regulatory Compliance Manager
3 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Summary:We are seeking an experienced Regulatory Compliance Manager to join our team at Fujifilm Diosynth Biotechnologies. This is an exciting opportunity to lead the development, implementation, and maintenance of individual sub-systems of the Pharmaceutical Quality Systems (PQS).The successful candidate will have expertise in Pharmaceutical Quality...
-
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeCompany Overview">FUJIFILM Holdings America Corporation is a leading global innovator in healthcare technology and medical imaging.">Job Description">As the Director of Quality Assurance for our Pharmaceutical Systems, you will be responsible for developing and implementing individual sub-systems of the Pharmaceutical Quality Systems (PQS) to ensure...
-
Compliance Auditor II
3 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob SummaryFUJIFILM Diosynth Biotechnologies seeks a highly skilled Regulatory Compliance Specialist II - Audit and Inspection Expert to join our team.In this critical role, you'll collaborate with site management to develop and implement effective quality systems, ensuring the organization's products meet the highest standards of quality, safety, and...
-
Quality Assurance Director
4 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob Description:Fujifilm Diosynth Biotechnologies seeks a highly skilled Director of Pharmaceutical Quality to lead the development, implementation, and maintenance of individual sub-systems of the Pharmaceutical Quality Systems (PQS).The successful candidate will be responsible for establishing governance and oversight processes to ensure compliance with...
-
Quality Assurance Analyst
2 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timeJob SummaryThe Senior QA Specialist will be responsible for ensuring the quality of products and services in a fast-paced environment. The ideal candidate will have a strong background in quality assurance and excellent analytical skills.Responsibilities- Review and approve documentation with minimal supervisory oversight- Draft and review internal quality...
-
Quality Assurance Manager
3 days ago
Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full timePosition DescriptionThe Validation Manager will lead the development and execution of validation plans and protocols to ensure compliance with regulatory requirements and industry standards. This role requires strong technical expertise, leadership skills, and effective communication skills.Main Duties:Leading validation teams and ensuring delivery of...
-
Regulatory Compliance Specialist
6 days ago
Hamilton, Waikato, New Zealand Hamilton City Council Full timeAbout the OpportunityWe are seeking an experienced investigator to join our team as a Regulatory Compliance Specialist. This role will play a crucial part in ensuring the city's water services comply with all relevant regulations and legislation.Key ResponsibilitiesConduct proactive and responsive inspections of non-compliance and breaches of HCC consent...
-
Senior Quality Assurance Expert
5 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeCompany OverviewFUJIFILM Diosynth Biotechnologies is a leading biopharmaceutical company with a strong commitment to innovation and quality. We are dedicated to advancing tomorrow's medicine and inspiring our employees to reach their full potential.We are seeking a highly skilled Senior Quality Assurance (QA) Analyst to join our team. As a key member of our...
-
Auditing and Compliance Specialist II
3 days ago
Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full timeJob DetailsThe Compliance Auditor II - Quality Assurance Specialist is responsible for ensuring FUJIFILM Diosynth Biotechnologies' products meet regulatory requirements and industry standards.This position works closely with site management to develop and implement effective quality systems, ensuring the organization's products meet the highest standards of...