We are seeking a dedicated professional to oversee the daily operations of our Quality Control laboratory. In this role, you will be responsible for ensuring that all analytical testing and laboratory activities align with strict quality standards. Your leadership will be crucial in maintaining the integrity of chemical and instrumental analysis, fostering a culture of precision, and ensuring that all results meet the necessary safety and efficacy benchmarks.
Roles and Responsibilities
Supervise daily laboratory workflows including chemical and instrumental analysis.
Review and authorize analytical data, test reports, and certificates of analysis.
Ensure all operations remain compliant with cGMP, GLP, and ICH regulatory frameworks.
Manage the maintenance and calibration of laboratory equipment such as HPLC, GC, and FTIR.
Lead investigations into out-of-specification (OOS) and out-of-trend (OOT) results, implementing CAPA as needed.
Coordinate method validation and verification activities for stability and finished products.
Desired Candidate Profile
Extensive experience in Quality Control within a pharmaceutical or biotech environment.
Comprehensive understanding of global regulatory standards including USFDA and WHO guidelines.
Technical expertise in handling advanced analytical instrumentation.
Proven ability to manage laboratory documentation, SOPs, and technical reports.
Strong supervisory skills with experience training and leading laboratory personnel.