QC Chemist
Purpose
To perform analytical chemistry services to support the manufacturing site, ensuring timely and accurate testing in compliance with cGLP, regulatory standards, and internal procedures. The QC Chemist plays a critical role in maintaining product quality and supporting cross-functional collaboration with departments.
Responsibilities
* Provide analytical chemistry services and support to Site.
* Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. Close contact maintained with Quality Assurance Production, Engineering and Planners.
* Maintain, update and issue chemical methods, specifications and SOP's in compliance to pharmacopoeia and regulatory requirements.
* Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP's and updates.
* Trend such results, record on COA's where required and complete OOS's investigations on a timely basis.
* Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
* Ensure all quality documentation and records are complete and current
* Ensure QC laboratories meet current Good Laboratory
* Practice (cGLP) requirements.
* Ensure relevant procedures are correctly defined and followed
* Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where required.
* Audit and review chemistry test results daily and ensure compliance with cGLP.
* Checking/auditing laboratory notebooks and analytical reports
Qualification
* BSc (Hons) or MSc in Chemistry, Biochemistry, or a related scientific discipline.
* 2+ years of experience in a GMP-regulated Quality Control laboratory environment (pharmaceutical, biopharmaceutical preferred).
* Experience in a range of analytical techniques, including UV spectroscopy, Karl Fischer titration (KF), HIAC particle analysis, SDS-PAGE, and HPLC.
* Previous IL33 Stability Testing.
* Strong understanding of cGLP, cGMP, and regulatory expectations (e.g., FDA, EMA).
* Familiarity with pharmacopoeia methods(e.g., USP, EP, BP).
* Competence in interpreting analytical results and troubleshooting laboratory instruments.
* Good documentation, organizational, and time-management skills.
* Proficiency with laboratory data systems and software (e.g.,LIMS, Empower, or equivalent).
* Strong attention to detail, with an ability to maintain high standards under pressure.
* Excellent communication and interpersonal skills, with a collaborative mindset.