We are looking for an experienced Laboratory Quality Control Manager to ensure that our products and services meet all necessary requirements before they reach the consumer.
Essential Duties And Responsibilities
• Responsible for managing the QC in accordance with GMP, customer and company requirements. Lead, organize and maintain all processes, procedures and administrative duties.
• Act as liaison with external parties on matters relating to QC testing status, approvals, rejections,documentation status, and any other QC matters to support all internal departments and customers.
• Develop and implement systems designed to support assay development, stability, raw material and finished product testing.
• Facilitate the evaluation of new testing applications and instrumentation. Assist in the purchase a of relevant instrumentation. Ensure there are efficient instruments for us.
• Provide guidance to resolve problems with instruments, test methods, lab chemicals, standards, and samples.
• Assure that all raw materials and finished goods are tested in accordance with all regulatory, and customer requirements, as applicable.
• Prepare justification for new lab equipment. Prepare purchase orders and coordinate authorization and procurement. Arrange installation and qualification.
• Manages process optimization program that includes continual improvement programs for analyses,human capital development and management systems Overall responsible for environmental monitoring program, including ensuring weekly monitoring and reporting is conducted and generating Impact Risk Assessments and quarterly/annual reports
• Overall responsible for stability programs and ensuring execution within required timelines. Continuous management, development and improvement of stability program.
• Overall responsibility to manage method validations/qualifications.
• Investigate deviations and write exception documents as required, utilizing problem solving tools as needed. Demonstrate familiarity with product specifications, regulations, and requirements.
• Responsible for investigating and processing Deviations, Out of Specifications, and Out of Trend, QC events.
-Proven experience as Laboratory Quality Control Manager
-Conscientious and responsible
-A keen eye for detail and a results driven approach
-Outstanding communication skills
-Excellent organizational and leadership skills
-In depth understanding of quality control procedures and relevant legal standards
-PhD in pharmaceutical sciences and MD/P.H.D in chemistry