Sr Manager, Qc - Quality


How will you make an impact?In this role, you will assure compliance and quality are defined, implemented, practiced, maintained and matured. This position is a leadership position leading, developing/mentoring, and overseeing the Quality Control Department for a API manufacturing site that is responsible for the execution of tests that are required by the customer for intermediates and final materials as well as the routine testing for raw materials, facilities, utilities, and manufacturing systems as applicable.What will you do? Direct laboratory operations in an organized and efficient manner to prevent any delays in product release. Manages the activities of the QC lab to assure that all test samples meet the in-process, raw materials, intermediate, final product, and stability specifications.Review and approve SOPs, validation protocols, investigations, batch records, analytical methods, specifications as they relate to this department.Work with the lab Managers and Supervisors to author Deviations, Change Controls, CAPAs, OOS/OOT investigations.Responsible for compliance of the QC laboratory and personnel.Participate in internal, client and regulatory audits.Interact with other departments as required to define and/or verify the scope of work for a particular project; e.g., Provide testing services for validation work.Responsible for the scientific and managerial training for the staff to assure a competent, professional, and committed work force. Ensure the completion of projects within budget limits and time projections.How will you get there:Education:Bachelors degree in relevant field, chemistry or other scientificExperience:5+ years of experience managing a pharmaceutical lab and a large team including supervisors and managers, preferably within a commercial product setting.10+ years of experience within a pharmaceutical laboratory setting.Knowledge, Skills, Abilities:Technical/Professional Knowledge having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.Safety and Security the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.Decision Making identifying and understanding issues, problems and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of ,+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Posted
05/05/2022
Location
Johannesburg, GT, ZA