Quality Control Analyst

About This Role

This Quality Control Analyst role is responsible for performing analyses of inputs and products at different stages of the process, executing stability tests, participating in process validation, and evaluating new suppliers. The role also involves applying analytical method validations and quality management systems, as well as following up on commitments related to safety, hygiene, and environmental care.

Responsibilities

• Execute physicochemical analyses of inputs, critical systems, stability studies, validation samples, and products, ensuring compliance with GMP, GLP, and established procedures.
• Perform sampling, analysis, documentation, and reporting of results, ensuring traceability of records and data integrity.
• Follow up on the calibration, qualification, and maintenance of instruments and equipment, and support the selection, purchase, installation, and qualification of new laboratory equipment, ensuring the validity of analyses and results.
• Manage the inventory of inputs and reagents required for laboratory operations and timely delivery of results.
• Develop, update, and maintain standard operating procedures, aligned with pharmacopoeias, directives, and current global documentation; understand and apply analytical method validations, and collaborate with the French team on the transfer of physicochemical, immunological, and microbiological analytical methods.
• Identify, evaluate, and control risks related to HSE and GxP, understanding and applying quality management systems (change control, deviations, and risk analysis), promoting continuous improvement and compliance with SMS 2.0 standards.
• Coordinate and follow up on HSE activities and indicators, participate in global meetings, and promote improvement initiatives within the Quality Control laboratory.

Requirements

• Knowledge in analytical physical chemistry, solid characterization, compliance with GMP, global quality policies, EHS, biosafety and biocontainment, digital systems, validation, verification, and transfer of physicochemical, immunological, and microbiological analytical methods, quality management systems (change control, deviations, and risk analysis), calibration and qualification of laboratory equipment, stability studies, interpretation of pharmacopoeias and regulatory standards, inventory and reagent management, performance indicators (KPI), chemical safety standards, and waste management.
• Strategic thinking and ability to analyze scenarios and make decisions.
• Results-oriented, adaptability, and ambiguity management.
• Leadership and ability to involve and leverage the strengths of others.
• Ability to build trusting relationships and influence different stakeholders.
• Focus on continuous improvement, problem-solving, and innovation.
• University degree in Pharmaceutical Chemistry, Chemistry, Biochemical Engineering, or related fields.