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Group Senior QA Associate

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITEDD01 Cecil, Marina, People’s Park, Raffles Place, SG

11 days ago

Job description

Roles & Responsibilities

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!

Tell employers what skills you have

Document Management

CAPA

Tolerance

Quality Management

Quality System

GMP

Chemistry

Computer System Validation

Audits

Change Control

Customer Focus

Regulatory Requirements

Stakeholder Management

Manufacturing

Audit

Able To Work Independently

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Senior Associate • D01 Cecil, Marina, People’s Park, Raffles Place, SG