Deskripsi Pekerjaan
Are you a meticulous and innovative analytical professional passionate about advancing pharmaceutical science? Combiphar, a leading Indonesian pharmaceutical company committed to delivering high-quality healthcare solutions, is seeking a dedicated Analytical Development Analyst to join our dynamic team in Padalarang, Jawa Barat.
In this crucial contract role, you will be at the forefront of developing and validating robust analytical methods for new and existing pharmaceutical products. Your expertise will directly contribute to ensuring the quality, safety, and efficacy of our medicines, impacting millions of lives across Indonesia. You will work within a state-of-the-art laboratory environment, utilizing advanced instrumentation and adhering to the highest GxP standards.
This is an exceptional opportunity for an individual with a strong background in analytical chemistry and pharmaceutical development to grow their career within a reputable and forward-thinking organization. If you thrive in a collaborative setting, possess strong problem-solving skills, and are eager to make a tangible difference in the pharmaceutical manufacturing landscape, we encourage you to apply. Join Combiphar and become a vital part of our mission to improve health and well-being through scientific excellence.
Tanggung Jawab
- Develop, optimize, and validate analytical methods for raw materials, in-process, and finished pharmaceutical products in accordance with ICH guidelines and pharmacopeial standards (USP, Ph. Eur., FI).
- Perform analytical testing using a range of sophisticated instruments including HPLC, GC, UV-Vis spectrophotometer, FTIR, and dissolution testers.
- Conduct stability studies and generate comprehensive data to support product shelf-life determination and regulatory submissions.
- Investigate Out-of-Specification (OOS) and Out-of-Trend (OOT) results, performing root cause analysis and implementing corrective actions.
- Prepare detailed analytical reports, method validation protocols, and standard operating procedures (SOPs) in compliance with GxP regulations.
- Maintain and calibrate laboratory equipment, ensuring operational readiness and data integrity.
- Collaborate effectively with Research & Development, Quality Control, and Production teams to support product development and manufacturing processes.
- Stay updated with the latest advancements in analytical technology and regulatory requirements in the pharmaceutical industry.
Kualifikasi
- Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or a related scientific discipline.
- Minimum of 2-3 years of proven experience in analytical development, quality control, or R&D within the pharmaceutical industry.
- Demonstrated proficiency in operating, troubleshooting, and maintaining analytical instruments, particularly HPLC and GC.
- Strong understanding and practical experience with analytical method development, validation, and transfer.
- Solid knowledge of GxP (GMP, GLP) regulations, ICH guidelines, and pharmacopeial requirements.
- Excellent analytical, problem-solving, and critical thinking skills with meticulous attention to detail.
- Ability to work independently as well as collaboratively within a team-oriented laboratory environment.
- Strong written and verbal communication skills; proficiency in English is a significant advantage.
- Familiarity with laboratory information management systems (LIMS) is a plus.