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 SOPs in compliance to pharmacopoeia and regulatory requirements.
Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOPs and updates.
Trend such results, record on COAs where required and complete OOSs 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 Qualifications 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).
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 Skills: Quality Control