Senior Associate of Quality Audit, System & Compliance
Salary undisclosed
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iNova was certified as a Best Place to Work in 2021. We are innovative, motivated, and passionately solution focused to support our customers in leading a healthy lifestyle. Join the team to experience the reasons why people love working for us!
The Opportunity
We currently have an opportunity for a Senior Associate of Quality Audit, System & Compliance, to join our Quality Assurance team on a full-time basis. Based in Singapore, this role will report into the Head of Audit System and Compliance.
The Senior Associate of Quality Audit, System & Compliance is responsible for the following:
To be successful in this role, you should possess a tertiary qualification (BSc or equivalent) in chemistry, pharmacy or a related Science or Engineering discipline. a related Science or Engineering discipline.
Other Key Requirements For This Role Include
iNova has a diverse portfolio of iconic brands across 20 countries including Australia & New Zealand, Asia and Africa and a dedicated team who put people's health first every day. With our unique blend of leadership and empowerment, we are just that little bit different and are proud of who we are.
Benefits
We know our people perform their best when they are happy and healthy at work, so we offer a range of benefits including:
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!
The Opportunity
We currently have an opportunity for a Senior Associate of Quality Audit, System & Compliance, to join our Quality Assurance team on a full-time basis. Based in Singapore, this role will report into the Head of Audit System and Compliance.
The Senior Associate of Quality Audit, System & Compliance is responsible for the following:
- To maintain a consistently high-quality standard across our product portfolio
- To maintain quality management systems in compliance with relevant competent authorities (e.g.. PICs GMP) and company compliance requirements
- To manage and maintain external manufacturing organisation quality compliance related to pharmaceutical international guidelines, food, medical device or other relevant guidelines and the business activities in the industry.
- To collaborate across functions to manage and ensure global internal quality compliance via the iNova Quality Management System; to create 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 collaborate with partners and functions in managing and conducting internal and external audits (suppliers and 3rd party audits)
- To develop and maintain Quality & Technical Agreements, supplier audits/ questionnaire, in line with changes in GxP guidelines
- To manage quality documentation including archival and retrieval of GMP documents in compliance with regulatory guidelines.
- To establish and maintain the QMS to ensure content is in compliance with regulations and work practices
- To manage and train staff on the quality documents involved, and the systems involved – Veeva (QMS), ComplianceWire (compliance training system)
- To maintain Site Master Files and Quality Manual.
- To oversee Corporate & Computer system validation QA.
- To ensure effective use of electronic documentation management system.
- To maintain and constantly improve the quality system
- To support functions in managing and engaging external manufacturers to ensure compliance to iNova quality requirements, and identify non-compliance.
- Document and Systems 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
- Manage timely rollout of training and ensure an up-to-date database in ComplianceWire
- Ensure system KPIs are in place, tracked, reported and actioned in a timely manner.
- Provide QA oversight for computer system validation
- Maintain and ensure Site Master File and Quality Manual are kept up to date.
- Ensure internal audit programme is kept up to date
- Manage and action on individual change controls within the defined target dates in compliance to GMP and iNova SOPs
- Manage individual deviations, NCR & CAPA processes, and action on them in compliance with GMP and iNova SOPs, and in alignment with timeframes of iNova’s business needs
- Provide QA oversight and support for computer system validation projects.
- Internal and External Auditing
- Lead and follow up on NCR/CAPA audits in a timely manner
- Ensure audits are conducted within the defined timeframes and in compliance to regulations and SOPs where applicable.
- Facilitate process to ensure that audit findings are resolved and closed out within the agreed timeframes where applicable.
- Collaboration and Stakeholder Management
- Drive a quality mindset across quality audit, system & compliance
- Collaborates closely with the wider iNova organisation to perform quality audit activities, and maintain system & compliance documents, policies, and procedures
- Takes initiative to support other functions in quality operations activities where relevant
- Functions as an integral part of the Quality Audit, System & Compliance team
To be successful in this role, you should possess a tertiary qualification (BSc or equivalent) in chemistry, pharmacy or a related Science or Engineering discipline. a related Science or Engineering discipline.
Other Key Requirements For This Role Include
- 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 organization in a commercial business
- 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 organization in a commercial business
- Experience in auditing within the industry will be preferred
- Working knowledge of Good Manufacturing Practice (GMP), computer system validation, deviation management, CAPA, change control and documentation management in a pharmaceutical / medical device industry
- Working knowledge of Good Distribution Practice (GDP) will be an advantage
- Good understanding of the various systems e.g., Quality Management System (QMS)
- High ambiguity tolerance and openness to change.
- Embrace a collaborative way of working when working with various 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’
- Adhere to company values at all times
iNova has a diverse portfolio of iconic brands across 20 countries including Australia & New Zealand, Asia and Africa and a dedicated team who put people's health first every day. With our unique blend of leadership and empowerment, we are just that little bit different and are proud of who we are.
Benefits
We know our people perform their best when they are happy and healthy at work, so we offer a range of benefits including:
- Hybrid working arrangements
- Health and wellness initiatives
- A thriving awards and recognition program
- And a day off for your birthday!
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!
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