job description
Are you a seasoned GxP Audit Services Expert with a passion for ensuring compliance and driving excellence in the life sciences industry? Bayer, a global leader in healthcare and agriculture, is seeking a highly skilled professional to join our team remotely from Bali, Indonesia. In this pivotal role, you will play a key part in upholding Bayerâs commitment to Science for a Better Life by conducting rigorous audits and fostering a culture of quality and compliance.
As a GxP Audit Services Expert, you will collaborate with cross-functional teams to assess compliance with Good Practice (GxP) regulations, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). Your expertise will help safeguard Bayerâs operations, ensuring that our products meet the highest standards of safety, efficacy, and quality. This role offers a unique opportunity to work in a dynamic, global environment while enjoying the flexibility of remote work in one of the worldâs most beautiful locations.
Bayer values innovation, integrity, and collaboration. If you are a detail-oriented professional with a strong background in GxP auditing and a desire to make a meaningful impact, we encourage you to apply. Join us in shaping the future of healthcare and agriculture while advancing your career in a supportive and forward-thinking organization.
Why Join Bayer?
- Opportunity to work with a globally recognized leader in life sciences.
- Remote work flexibility from Bali, Indonesia.
- Competitive salary and comprehensive benefits package.
- Professional development and growth opportunities.
- Contribute to meaningful projects that improve lives worldwide.
Responsibility
- Conduct comprehensive GxP audits (GMP, GLP, GCP) to ensure compliance with regulatory requirements and Bayerâs internal standards.
- Develop and implement audit plans, including risk assessments and audit schedules, to evaluate the effectiveness of quality systems.
- Identify compliance gaps, recommend corrective actions, and track their implementation to closure.
- Collaborate with internal stakeholders, including Quality Assurance, Manufacturing, and R&D teams, to drive continuous improvement in GxP processes.
- Prepare detailed audit reports, including findings, observations, and recommendations, for senior management and regulatory bodies.
- Stay updated on global regulatory trends, guidelines, and best practices related to GxP compliance.
- Provide training and guidance to Bayer employees on GxP requirements and audit processes.
- Support regulatory inspections and external audits by providing expertise and documentation as needed.
Qualifications
- Bachelorâs degree in Pharmacy, Chemistry, Biology, Engineering, or a related life sciences field. Advanced degree or certification (e.g., RAC, CQA) is a plus.
- Minimum of 5 years of experience in GxP auditing, preferably within the pharmaceutical, biotechnology, or medical device industries.
- Strong knowledge of global GxP regulations, including FDA, EMA, ICH, and other relevant guidelines.
- Proven experience in conducting audits, risk assessments, and compliance evaluations.
- Excellent analytical, problem-solving, and communication skills, with the ability to present complex information clearly and concisely.
- Detail-oriented with a strong commitment to accuracy and quality.
- Ability to work independently and remotely while managing multiple priorities in a fast-paced environment.
- Fluency in English; additional languages are a plus.