Apply on
Company Overview
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it is our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
About the role
Arcondis Singapore is seeking a Quality SME to provide comprehensive quality oversight for validation activities, including Data Integrity. The candidate will work closely with validation teams, ensuring compliance, risk mitigation, and process improvement throughout qualification activities.
Key Responsibilities:
- Serve as a key member of the Quality Systems team, ensuring quality oversight for validation activities, with a focus on Data Integrity.
- Collaborate with Subject Matter Experts to assist the validation team in gap analysis/risk assessments before qualification activities, proposing mitigation plans for identified gaps.
- Participate in validation discrepancy investigations, and assist with the review and approval of discrepancy reports, supporting CAPA closures.
- Review and approve validation documents, including protocols, reports, and related documentation.
- Provide guidance on validation queries and issues throughout the process.
- Review and approve routine SOPs, forms, and other relevant procedures, including Manufacturing Batch Records.
Qualifications:
- Strong experience in quality oversight for validation activities, with knowledge of Data Integrity requirements.
- Proficiency in conducting gap analysis/risk assessments and proposing effective mitigation strategies.
- Experience in discrepancy investigations and CAPA management.
- Expertise in reviewing and approving validation documents and operational procedures.
- Excellent communication and problem-solving skills, with a focus on compliance and quality improvement.
Why Arcondis
- An opportunity to shape the future of healthcare by spearheading transformative deals.
- A collaborative and innovative work environment, where your ideas are valued, and your contributions make a significant impact.
- Flexible working environment, enabling work-life balance.
- Attractive compensation package, inclusive of performance-based incentives that reward exceptional achievements.
- Professional growth and development opportunities
