Quality Control Staff

PT Mersifarma TM; Sukabumi; On-site; IDR 78,120,000 - 122,760,000; Full time

Job summary

PT Mersifarma TM seeks a QA/QC professional to perform sampling, testing, and inspection of materials and products in accordance with approved procedures. The role emphasizes GMP compliance, GDP documentation, and cross-functional collaboration to uphold product quality.

Ideal candidates have a chemistry or pharmacy background, 1 year in pharmaceutical QC, and familiarity with HPLC, GC, UV-Vis, FTIR, or dissolution testing. Flexibility to work in shifts is valued.

Qualifications

• Bachelor's degree in Chemistry or Pharmacy required.
• Minimum 1 year of QC experience in the pharmaceutical industry preferred; fresh graduates are welcome to apply.
• Strong understanding of GMP/cGMP and GDP.
• Familiarity with lab techniques and instruments (HPLC, GC, UV-Vis, FTIR, Dissolution Tester) is advantageous.
• Proficient in Microsoft Office applications, especially Excel and Word.
• Strong analytical thinking, attention to detail, and problem-solving skills.
• Willing to work in shifts when required.
• Demonstrates high integrity and commitment to quality and regulatory standards.

Responsibilities

• Perform sampling, testing, and inspection of raw materials, packaging materials, intermediates, bulk, and finished products per approved procedures.
• Ensure all QC activities comply with SOPs, product specifications, and GMP/cGMP.
• Conduct physical, chemical, and/or microbiological analyses using validated methods.
• Operate, maintain, and verify laboratory equipment; report abnormalities.
• Record and document testing results accurately and promptly per GDP.
• Identify, report, and support investigations related to OOS results and deviations.
• Collaborate with Production, QA, and cross-functional teams to resolve quality concerns.
• Ensure laboratory activities comply with GMP/cGMP and Quality Management System.
• Participate in method validation, method transfer, equipment qualification, calibration, and continuous improvement.
• Maintain laboratory cleanliness, safety, and organization per EHS policies.

Skills

Analytical thinking

Attention to detail

Problem-solving

Teamwork abilities

Education

Bachelor's Degree in Chemistry

Professional Pharmacy Degree (Licensed Pharmacist/Apothecary)

Tools

Microsoft Excel

Microsoft Word

Job description

• Perform sampling, testing, and inspection of raw materials, packaging materials, intermediate products, bulk products, and finished products in accordance with approved procedures.
• Ensure all quality control activities comply with Standard Operating Procedures (SOPs), product specifications, and Good Manufacturing Practices (GMP/cGMP).
• Conduct physical, chemical, and/or microbiological analyses (as applicable) using validated analytical methods.
• Operate, maintain, and verify laboratory equipment to ensure proper functionality, and report any abnormalities or equipment issues.
• Record and document testing results accurately, completely, and in a timely manner in accordance with Good Documentation Practices (GDP).
• Identify, report, and support investigations related to Out of Specification (OOS) results, deviations, and other quality-related issues.
• Collaborate with the Production, Quality Assurance, and other cross-functional teams to resolve quality concerns and maintain product quality standards.
• Ensure laboratory activities comply with GMP/cGMP requirements, regulatory standards, and the company's Quality Management System.
• Participate in analytical method validation, method transfer, equipment qualification, calibration, and continuous quality improvement initiatives, as required.
• Maintain laboratory cleanliness, safety, and organization in compliance with EHS (Environment, Health & Safety) policies and company regulations.

Job Qualifications:

• Bachelor's Degree in Chemistry or a Professional Pharmacy Degree (Licensed Pharmacist/Apothecary).
• Minimum 1 year of experience in Quality Control within the pharmaceutical industry is preferred; fresh graduates are welcome to apply.
• Strong understanding of Good Manufacturing Practices (GMP/cGMP) and Good Documentation Practices (GDP).
• Familiarity with laboratory analytical techniques and instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Tester, or other analytical equipment is an advantage.
• Proficient in Microsoft Office applications, particularly Microsoft Excel and Word.
• Strong analytical thinking, attention to detail, and problem-solving skills.
• Excellent communication and teamwork abilities.
• Willing to work in shifts when required.
• Demonstrates high integrity and a strong commitment to quality, compliance, and regulatory standards within the pharmaceutical industry.