job description
Join a global leader in pharmaceutical innovation as a QC Chemist / Biotechnologist in Bali, Indonesia. This is a rare opportunity to contribute to cutting-edge research and quality control processes in a fast-growing, top-tier multinational corporation (MNC).
As part of our dynamic team, you will play a pivotal role in ensuring the highest standards of product quality, compliance, and safety. This position offers a competitive salary, career growth, and the chance to work in a state-of-the-art facility with a collaborative, forward-thinking culture.
If you are a detail-oriented professional with a passion for biotechnology and quality assurance, we want to hear from you. Apply now to seize this exciting career opportunity in one of the most sought-after industries.
Responsibility
- Conduct quality control testing on raw materials, in-process samples, and finished pharmaceutical products using advanced analytical techniques (HPLC, GC, UV-Vis, etc.).
- Ensure compliance with GMP, GLP, and ISO standards in all laboratory operations.
- Prepare and review SOPs, protocols, and technical reports for accuracy and regulatory adherence.
- Investigate and resolve deviations, OOS (Out-of-Specification) results, and non-conformances with root cause analysis.
- Collaborate with cross-functional teams (R&D, Production, Regulatory) to support product development and commercialization.
- Maintain and calibrate laboratory equipment to ensure optimal performance and reliability.
- Participate in audits (internal/external) and implement corrective actions as needed.
- Stay updated with industry trends, regulatory changes, and emerging technologies in biopharmaceutical QC.
Qualifications
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, Biotechnology, Pharmacy, or a related field.
- Minimum 3-5 years of experience in QC testing for pharmaceuticals/biologics in a GMP environment.
- Hands-on experience with chromatography (HPLC/UPLC), spectroscopy, and wet chemistry techniques.
- Strong knowledge of ICH, USP, EP, and local regulatory guidelines (e.g., BPOM, FDA, EMA).
- Proficient in LIMS (Laboratory Information Management Systems) and data analysis tools.
- Excellent problem-solving, documentation, and communication skills.
- Ability to work in a fast-paced, high-compliance environment with minimal supervision.
- Certifications in GMP, Six Sigma, or Lean Manufacturing are a plus.