Job Title: API Quality Control Analyst
Company Overview:
At [Company Name], we are steadfast in our mission to deliver safe and effective pharmaceutical products that improve lives. We firmly believe that the integrity of a finished medicine begins with the uncompromising quality of its Active Pharmaceutical Ingredients (APIs) and other foundational materials. Our commitment to patient well-being drives a rigorous quality control process, ensuring that every component meets the highest standards before contributing to our essential medications. Join us in upholding the quality that underpins global health.
About the Role:
We are seeking a dedicated and meticulous API Quality Control Analyst to join our dynamic team. This critical role is central to our quality assurance framework, responsible for meticulously testing and verifying the quality of all incoming Active Pharmaceutical Ingredients. If you possess a keen analytical mind, a solid foundation in pharmaceutical sciences, and a passion for ensuring patient safety through stringent quality control, this is an exceptional opportunity to make a tangible impact at the very start of the pharmaceutical manufacturing process.
Key Responsibilities:
As an API Quality Control Analyst, your primary duties will include:
- Performing comprehensive analytical testing on Active Pharmaceutical Ingredients and critical starting materials according to established pharmacopoeial methods and in-house specifications.
- Executing tests for key quality attributes such as Identification, Assay, Related Substances, Water/Moisture content, Sulphated Ash / Residue on Ignition, Residual Solvents, Elemental Impurities, Chiral Purity, Genotoxic Impurities, and Particle Size / Appearance.
- Operating and troubleshooting a variety of advanced analytical instruments, including FTIR, HPLC, UV, Titration apparatus, Karl Fischer titrators, Headspace GC, ICP-MS, and ICP-OES.
- Rigorously interpreting and comparing analytical results against predefined API specifications and Certificates of Analysis (CoA).
- Initiating thorough Out-of-Specification (OOS) investigations, including reviewing calculations, sample preparation, and instrument performance, and reporting findings promptly to responsible personnel.
- Ensuring strict adherence to Good Manufacturing Practices (GMP) and relevant international guidelines, including ICH Q3A (API impurities), ICH Q3C (Residual Solvents), ICH Q3D (Elemental Impurities), and ICH M7 (DNA-reactive/genotoxic impurities).
- Maintaining meticulous documentation of all analytical procedures, raw data, and results.
Required Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a closely related scientific discipline.
- Strong theoretical and practical understanding of analytical chemistry principles and laboratory techniques.
- Familiarity with various analytical instruments commonly used in pharmaceutical quality control.
- Knowledge of pharmaceutical quality control methodologies and relevant ICH guidelines concerning API impurities.
- Exceptional attention to detail, strong problem-solving capabilities, and the ability to work effectively both independently and as part of a collaborative team.
What We Offer:
- A pivotal role in ensuring the quality and safety of pharmaceutical products that reach patients worldwide.
- An opportunity to work within a state-of-the-art laboratory environment, utilizing cutting-edge analytical instrumentation.
- Professional growth and continuous learning opportunities within the pharmaceutical industry.
- A collaborative and supportive work culture dedicated to excellence and innovation.
How to Apply:
If you are eager to apply your scientific expertise to a role where quality truly begins, we invite you to join our team. Please submit your resume and a cover letter detailing your qualifications and interest in this API Quality Control Analyst position through our official careers portal.
