About the company
One of the global healthcare & FMCG business in Singapore. This is a great opportunity for a proactive candidate to take more accountability and responsibility to partner with the business.
About the role
A great opportunity for an individual contributor to work closely with the business and reporting into the Global Head Quality Audit. This role will be part of the compliance team and part of the broader global SQC team. This role will lead quality assurance audits, inspections (internal and external) and monitor procedures against Standard Operation Procedures (SOPS), methods, protocols and relevant regulations/ guidelines.
- Conduct audits of Manufacturing, R&D, Distribution Centres and Commercial sites within their region to ensure consistent compliance against minimum quality and compliance standards and applicable regulatory requirements.
- Generate detailed audit reports specifying identified gap, areas for improvement and recommendations.
- To conduct follow up visits, as required, to sites identified as High Risk
- To work with Regional Quality and Compliance (Q&C) Managers to ensure all actions are fully closed out in line with expectations
- Provide coaching and mentoring to enhance organizational compliance
- Define and deploy best practices
- To escalate issues / concerns to Regional Directors, SVPs, GQLT and the GSLT
- Be willing to travel 50% - 60% in the region
- Hold a Degree in Pharmacy, Chemistry or other scientific related field
- 8-10 years' experience working with drug, medical device, cosmetics, Reach compliance in Pharmaceutical and/ or Consumer Health Industry.
- Experience specifically experience in quality systems, regulatory affairs or regulatory compliance preferred
- 3 years' experience conducting quality and compliance audits
- Good understanding of Quality and compliance regulations related to a manufacturing R&D, Distribution Centres and Commercial sites site in one or more countries.
- Experience working with one or more of the following regulatory Agencies FDA, EPA MHRA, ANVISA, CFDA, EMA etc
EA Registration Number: R1766531
Argyll Scott Singapore Pte Ltd. EA Licence Number: 16S8105