Location: Jakarta Barat
Employment Type: Full Time
Department: R&D/Analytical Research
Reporting to: RD Lead
Required Experience: Minimum 3 years
Job Summary
We are looking for a detail-oriented and knowledgeable Analytical Scientist to support our laboratory operations, method validation activities, and compliance with regulatory and compendial standards. This role focuses on analytical method development/validation, laboratory documentation, and ensuring that all testing activities meet GMP requirements and internal quality standards.
Key Responsibilities
- Manage and maintain laboratory documentation, including SOPs, STPs, protocols and reports.
- Assist in writing, reviewing, and updating Standard Operating Procedures and Standard Test Procedures in alignment with GMP, PQS, and compendial requirements (FI, USP, BP, etc.).
- Perform analytical and trials, verification activities, prepare protocols and reports, and ensure timely execution of project deliverables.
- Support the implementation and monitoring of compendial compliance within the laboratory.
- Support QC/R&D teams in laboratory investigations, including handling out-of-specification (OOS) cases.
- Ensure reagents, reference standards, and laboratory equipment are properly maintained and ready for testing.
- Provide necessary training to laboratory personnel regarding analytical procedures, documentation, and compliance.
Qualifications
- Bachelor's Degree in Chemistry or Pharmacy.
- Minimum 3 years of experience in analytical method development, validation, or laboratory compliance in the pharmaceutical industry.
- Strong knowledge of analytical instruments and test procedures (HPLC, UV-Vis, FTIR, dissolution tester, etc.) and familiarity with compendial requirements (USP, FI, BP, etc.).
- Understanding of GMP, GLP, and regulatory compliance requirements in pharmaceutical manufacturing.
- Strong analytical thinking, attention to detail, and high integrity.
- Ability to work independently and collaboratively within cross-functional teams.
- Good communication and interpersonal skills.
- Experience in laboratory investigation and documentation for OOS or deviations.
