Qualifications Education o Master s degree in a relevant scientific discipline e g Chemistry Biochemistry or M Pharm Experience 8-12 years Proven experience in a Quality Assurance role within a bioanalytical laboratory or related GxP environment pharmaceutical CRO Specific experience with GLP and or GCP regulations is often essential Experience with auditing bioanalytical studies and systems Experience with different bioanalytical techniques e g LC-MS MS ELISA Computer System Validation data review Major regulatory inspections handling experience in a Bioanalytical QA role signifies a high level of expertise in regulatory compliance quality assurance and the ability to navigate critical interactions with health authorities to ensure the integrity and acceptability of bioanalytical data Skills o Thorough understanding of GLP GCP and other relevant regulatory guidelines o Strong auditing skills and techniques o Excellent attention to detail and analytical skills o Strong written and verbal communication skills o Ability to interpret and apply regulations and guidelines o Problem-solving and critical thinking skills o Ability to work independently and as part of a team o Proficiency in Microsoft Office Suite o Familiarity with Laboratory Information Management Systems LIMS Responsibilities This section details the specific tasks and duties the Bioanalytical QA skilled will be responsible for Auditing o Planning conducting and reporting internal and external audits of bioanalytical studies facilities and systems to ensure compliance with Good Laboratory Practice GLP Good Clinical Practice GCP and other relevant regulations e g FDA EMA WHO ICH guidelines o Auditing study protocols analytical methods validation reports and study reports o Auditing laboratory procedures documentation and data o Following up on audit findings to ensure effective corrective and preventive actions CAPAs are implemented o Conducting vendor audits as required Compliance o Ensuring bioanaly