QA/ Qc Manager

2 days ago

Singapore ENERGY ALLOYS PTE. LTD. Full time

Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant business stakeholders, and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
- Participates in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
- Promotes standardization of auditing approach within QA.
- May represent QA as a single point of contact and provide QA guidance for studies in a certain TA or in certain countries to achieve continuous quality improvement and effective quality assurance.
- Interfaces with relevant stakeholders, including regulatory, development sub-teams, as appropriate to provide QA expertise.
- Contributes to the QA strategy and supports QA goals for the aligned studies/countries in the Region.
- Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
- In alignment with risk assessments, supports the identification of audit substrate for scheduling, as appropriate.
- Actively contributes to the quality management oversight, in the development of clinical risk assessments and quality oversight initiatives (quality plan, quality agreements) as needed.
- Support Significant Quality Issues management for assigned studies, including assessment of potential root causes and remediation (corrective and preventative actions) as needed.
- Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL, TA Head and Operations manager.
- Provides inspection management support as appropriate.
- Develops and delivers awareness sessions with mínimal supervision on various topics internally and externally.
- Acts as a strong technical resource and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), regulations and guidelines as well as local regulations.
- Routinely suggests new audit techniques/aids in areas of technical expertise
- Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
- Provides training and mentorship to less experienced members of QA staff

**Skills, Knowledge, Experience & Qualifications Required**
- Education/Experience BS/BA degree in relevant area with significant experience in field and experience in the Marine industry including experience conducting a broad range of audits.
- In-depth knowledge of all applicable regulations is essential.
- Business Acumen/Attention to Detail
- Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
- Familiarity with existing company systems, policies and procedures and knowledge of including all projects/premier products is desirable.
- Other important skills to be successful in this role would be ability to work independently, use rigorous logic and methods to solve difficult, ability to communicate complex information and analysis to a variety of scientific and non
- scientific audiences in both verbal and written formats, leadership, teamwork,
- Ability to influence and negotiate with key stakeholders

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