job description
Are you a seasoned Quality Control Specialist with expertise in Method Validation and Technical Support? Amaris Consulting is seeking a detail-oriented professional to join our dynamic team in Bali, Indonesia. In this pivotal role, you will ensure the highest standards of product quality, compliance, and process optimization in a fast-paced, innovative environment.
As a Senior QC Specialist, you will lead method validation initiatives, troubleshoot technical challenges, and collaborate with cross-functional teams to uphold regulatory standards. This is a unique opportunity to contribute to cutting-edge projects while enjoying the vibrant culture and work-life balance of Bali.
If you are passionate about precision, problem-solving, and driving excellence in quality assurance, we invite you to apply and take the next step in your career with a global leader in consulting and engineering solutions.
Responsibility
- Lead and execute method validation activities in accordance with GMP, GLP, and other regulatory guidelines.
- Develop, review, and optimize standard operating procedures (SOPs) and analytical methods for quality control testing.
- Provide technical support to production, R&D, and external stakeholders to resolve quality-related issues.
- Conduct root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for deviations and non-conformances.
- Ensure compliance with international quality standards (e.g., ISO, FDA, ICH) and internal quality systems.
- Train and mentor junior QC staff on best practices in testing methodologies and data integrity.
- Collaborate with cross-functional teams to improve process efficiency and product quality.
- Prepare and review technical reports, validation protocols, and regulatory documentation.
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biochemistry, or a related scientific field.
- Minimum 5 years of experience in Quality Control, Method Validation, or Analytical Development within the pharmaceutical, biotech, or medical device industry.
- In-depth knowledge of GMP, GLP, ICH, and FDA regulations.
- Hands-on experience with HPLC, GC, UV-Vis, dissolution testing, and other analytical techniques.
- Strong problem-solving, data analysis, and technical writing skills.
- Proven ability to lead validation projects and manage timelines effectively.
- Excellent communication and interpersonal skills to collaborate with global teams.
- Familiarity with LIMS (Laboratory Information Management Systems) is a plus.