job description
Join Darya-Varia Laboratoria, a leading pharmaceutical company, as a Stability Study Specialist in beautiful Bali. This role is pivotal in ensuring our products meet the highest regulatory standards through comprehensive stability testing and quality assurance processes.
As part of our dedicated Quality Control team, you will play a key role in designing, executing, and monitoring stability studies for our diverse product portfolio. Your expertise will directly contribute to maintaining compliance with GMP, ICH, and local regulatory requirements, while supporting product development and lifecycle management.
This is a unique opportunity to work in a dynamic, science-driven environment where your contributions will have a tangible impact on public health. Baliās vibrant culture and serene landscapes provide an inspiring backdrop for your professional growth.
Responsibility
- Design and implement stability study protocols in accordance with ICH, GMP, and local regulatory guidelines.
- Conduct and supervise stability testing for raw materials, in-process samples, and finished products.
- Analyze stability data and prepare comprehensive reports for regulatory submissions.
- Collaborate with R&D and production teams to ensure product formulations meet stability requirements.
- Monitor environmental conditions in stability chambers and maintain accurate documentation.
- Identify and investigate deviations or out-of-specification (OOS) results, proposing corrective actions.
- Stay updated with evolving regulatory standards and industry best practices for stability testing.
- Support internal audits and inspections by regulatory authorities.
Qualifications
- Bachelorās degree in Pharmacy, Chemistry, Biochemistry, or related fields; Masterās degree is a plus.
- Minimum 3 years of experience in stability studies, quality control, or pharmaceutical analysis.
- In-depth knowledge of ICH Q1A(R2), GMP, and ISO 17025 standards.
- Hands-on experience with HPLC, GC, UV-Vis spectroscopy, and dissolution testing.
- Proficiency in stability data management systems (e.g., LIMS, Empower).
- Strong analytical, problem-solving, and report-writing skills.
- Excellent communication skills in English (written and verbal).
- Attention to detail and commitment to data integrity.