Group Senior QA Associate

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 monitoring
  • To support external audits as required
  • To 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 SOPs
• Write, 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 SOPs
• Conduct 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 QMS
• Maintain 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 SOPs

2. Continuous improvement

• Support internal and external audits to ensure audit findings are resolved within the agreed timeframes
• Drive continuous improvement of QMS function by tracking partner performance against KPIs, conducting root-cause analysis, reviewing, and identifying opportunities to improve quality processes
• Collaborate with other functions to develop and establish improvement programmes / best practices for the global quality function
• Collaborate 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 function
• Collaborates closely with the wider iNova organisation to ensure quality activities are completed and in compliance to regulation requirements and SOPs
• Work with other functions in developing global continuous improvement programmes
• Takes initiative to support other functions in quality operations activities where relevant
• Functions as an integral part of the Quality team

About 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 business
• Working knowledge of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), deviation management, CAPA, change control and documentation management in a pharmaceutical / medical device industry
• Good 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 teams
• Practice a growth mindset; to continually learn and improve
• Able to handle multiple tasks in a fast-paced environment
• Be able to work independently by taking ownership of their work and identifying appropriate next steps required to deliver on their work
• Understands and embraces change and the transformation agenda
• Strong customer focus (with respect to internal and external ‘customers’)

Additional Requirements / Working Conditions

• Adhere to company values at all times
  

If 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!