Job Overview
The In Process Control (IPC) Staff position within the Quality Department is integral to maintaining and improving our organization's quality standards. The successful candidate will engage in activities that ensure compliance with quality assurance guidelines, contributing to the overall effectiveness of our processes.
Roles and Responsibilities
- Operate, maintain, and troubleshoot analytical instruments (HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus, etc.).
- Perform method development, method validation, and routine analysis for in-process and finished products.
- Monitor critical process parameters and ensure compliance with specifications and regulatory requirements.
- Conduct process capability studies, stability testing, and data trending.
- Document and report analytical results in compliance with GMP, GLP, and ISO standards.
- Support process investigations (OOS, deviations, root cause analysis).
- Collaborate with QA, Production, and R&D teams to optimize process control and product consistency.
Key Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or related field.
- At least internship experience on relevant position (within pharmaceutical, biotech, or F&B industry is a huge advantage)
- Hands-on experience in HPLC operation, troubleshooting, and data analysis.
- Familiarity with analytical method validation, ICH guidelines, and regulatory compliance (BPOM, FDA, EMA).
- Proficiency in laboratory software (e.g., Empower, Chromeleon, or other chromatography data systems).
- Strong analytical and problem-solving skills with attention to detail.
- Good communication and teamwork abilities.
- Willing to work in shifts & placed in Sukabumi Factory