Analytical Scientist

Tanggung Jawab

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.

Kualifikasi

• Bachelor’s Degree in Chemistry or Pharmacy.
• 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.
• Available to join immediately (ASAP)