About iNova
iNova is a different kind of health company. We are leading the way to better health by delivering innovative, patient-centric products that improve the lives of people around the world. Our diverse portfolio of iconic, market-leading consumer health brands and prescription medicines are backed by science and distributed in over 75 markets across Asia, Australia, New Zealand, Middle East & Africa and Europe. Experience the iNova difference today.
The Opportunity
We currently have an opportunity for Group Senior QA Associate to join our Quality team on a permanent full-time basis.
The Group Senior QA Associate for Global Centre of Excellence (COE) is responsible for the following :
- To provide advice to Quality operations team relating to prescription product portfolio when required
- To ensure overall QMS quality operations are performing against KPIs; drive continuous improvement of QMS function by establishing and managing quality process improvement programmes and best practices (in collaboration with other quality functions) to refine global quality processes
- To drive and implement consistent global quality processes
- To manage data & analytics capabilities and KPIs relevant to the performance management and oversight of all quality issues
- To work with quality operations team in the implementation of established continuous improvement programmes with the EMO and Distributors.
- To collaborate across functions, creating a more collaborative quality function, and drive a quality mindset throughout the organisation
- To maintain policies, procedures and quality systems in compliance with a) government guidelines, b) regulations or work practices; and c) corporate expectations
- To be responsible for the following areas :
To write, review & / or authorise Quality documents and procedures as defined e.g. SOPs, WIs, forms, PQR, Deviation and Quality investigation reports
To maintain and manage Quality Management System (QMS) e.g. Change Control, Deviations & CAPA, Customer Complaints, including associated Metrics as part of performance monitoringTo support external audits as requiredTo drive constant improvement of the quality system.Key Responsibilities
The following outlines the accountabilities and deliverables of the Group Senior QA Associate for Global Centre of Excellence (COE) :
1. Quality Document Management
Maintain and update Veeva documents within the required due dates in compliance with regulations and iNova SOPsWrite, maintain, update, review & / or authorise Quality documents and procedures (e.g. SOPs, WIs, forms, Deviation and Quality investigation reports) in compliance with regulations and iNova SOPsConduct training if required and inform Quality Audit, System and Compliance team to update ComplianceWire on training assignment to ensure timely roll-out of training.Ensure system KPIs are in place, tracked, reported and actioned in a timely manner.Provide QA oversight for computer system validation on Veeva QMSMaintain and ensure Site Master File and Quality Manual are kept up to date.Manage and action on individual change controls within the defined target dates in compliance to GMP and iNova SOPs2. Continuous improvement
Support internal and external audits to ensure audit findings are resolved within the agreed timeframesDrive continuous improvement of QMS function by tracking partner performance against KPIs, conducting root-cause analysis, reviewing, and identifying opportunities to improve quality processesCollaborate with other functions to develop and establish improvement programmes / best practices for the global quality functionCollaborate with other functions to ensure new regulatory requirements (eg : Residual solvents assessment, Nitrosamine assessment) and being met and updated on relevant QMS processes and SOPs.3. Collaboration and stakeholder management
Drive a quality mindset across the global quality operations functionCollaborates closely with the wider iNova organisation to ensure quality activities are completed and in compliance to regulation requirements and SOPsWork with other functions in developing global continuous improvement programmesTakes initiative to support other functions in quality operations activities where relevantFunctions as an integral part of the Quality teamAbout You
A tertiary qualification (BSc or equivalent) in chemistry, pharmacy or a related Science or Engineering discipline.Minimum 5 years in the pharmaceutical / medical device industry with at least 3 years of QA experience in the pharmaceutical or medical device industry. Experience in supply chain quality, manufacturing quality or quality organisation in a commercial businessWorking knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), deviation management, CAPA, change control and documentation management in a pharmaceutical / medical device industryGood understanding of the Quality Management System (QMS)Personal Attributes
High ambiguity tolerance and openness to change.Embrace a collaborative way of working when working with other teamsPractice a growth mindset; to continually learn and improveAble to handle multiple tasks in a fast-paced environmentBe able to work independently by taking ownership of their work and identifying appropriate next steps required to deliver on their workUnderstands and embraces change and the transformation agendaStrong customer focus (with respect to internal and external ‘customers’)Additional Requirements / Working Conditions
Adhere to company values at all timesIf you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY! We want you to join us in our pursuit of healthy living!