Description
method development
method validation
chromatography
data analysis
gmp compliance
regulatory audits
The Senior QC Analyst will perform testing of pharmaceutical substances, such as raw materials and drug substances, in a GMP environment following ISL procedures. Work will centre on chromatography (HPLC, UPLC, GC) and other analytical techniques as required.
- Lead and execute routine and non‑routine QC testing in compliance with cGMP and approved methods.
- Serve as technical SME for chromatographic techniques (HPLC, UPLC, GC) and detectors (UV/Vis, PDA, MS).
- Independently develop, optimize, and troubleshoot chromatographic methods, including mobile phases, gradients, columns, flow rates, temperatures and injection parameters.
- Design and conduct method development studies assessing specificity, robustness, linearity, sensitivity and overall performance.
- Perform forced degradation and stability‑indicating studies to demonstrate method specificity.
- Plan, execute and review full analytical method validation packages aligned with ICH Q2(R2) (accuracy, precision, specificity, linearity, range, robustness, LOD, LOQ).
- Author, review and approve method development reports, validation protocols, validation reports and technical justifications.
- Provide technical oversight for method transfers, analytical lifecycle management and continuous improvement initiatives.
- Conduct advanced data analysis including chromatographic integration, impurity profiling and data trending.
- Lead or support OOS/OOT investigations, root‑cause analysis and implementation of CAPA.
- Ensure data integrity, high‑quality documentation and strict adherence to GMP, SOPs and regulatory expectations.
- Support regulatory inspections, client audits and internal audits as QC representative.
- Mentor and provide technical guidance to junior QC analysts.
Requirements
hplc
lims
trackwise
gmp
bachelor's
leadership
A strong focus on integrity, consistency, flexibility and professionalism is expected, along with compliance to SGS policies, effective teamwork, strong analytical problem‑solving, and excellent written and verbal communication.
- Possess expert‑level hands‑on experience with HPLC, UPLC and GC; detector experience with UV/Vis, PDA, MS is desirable.
- Hold a Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related field (advanced degree preferred) and 4+ years of GMP QC or analytical development experience.
- Demonstrated leadership in analytical method development, optimization and validation activities.
- Strong knowledge of ICH Q2(R2), GMP regulations and data integrity requirements.
- Proficient with LIMS, TrackWise and other laboratory computer systems.
- Exhibit strong organizational, communication and teamwork skills, with a customer‑service mentality and commitment to quality and safety.
Benefits
The role offers a pharma‑benchmark salary, performance‑related bonus, medical insurance, pension, illness income protection and enhanced vacation, with typical office hours and flexitime arrangements. The position emphasizes personal development and provides attractive compensation and benefits.
Training + Development
Information not given or found
