Responsible for leading the Quality Control team to ensure compliance with all Corporate and local policies, procedures, and regulations, while supervising in a cGMP environment.
Schedule laboratory testing and provide resource and instrumentation allocation, conducts laboratory investigations, and implement and monitor corrective actions.
Ensure timely testing and notification of any aberrant occurrence to Management that presents a potential negative impact on manufactured or marketed products.
Monitor and maintain quality programs that provide assurance that test specifications are met for raw materials, finished products, intermediates, and stability testing.
Work cross-functionally to coordinate testing schedules and communications in support of the weekly production activities and ensure QC testing and maintenance activities are completed per requirements.
Verify, review and make appropriate changes if needed, to any controlled document(s) pertinent to the area of responsibility.
Ensure team compliance with all policies, procedures, and site/company regulations.
Coach and develop the team to High Performance while fostering a culture of team ownership. Recognize and reward performance.
Set a clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
Provide leadership for employees through effective communication, coaching, training, and development and provide solutions for the success of the team.
Conduct daily Huddle board meetings to update employees and track progress.
Measure and communicate team progress against individual, team, and site goals and Key Performance Indicators (KPIs).
Manage the department overtime (OT) and ensure that all exception reports are completed and submitted as required.
Maintain an acceptable level of 5S in the area and promote proper maintenance and cleanliness of the department areas of responsibility.
Assure compliance with department training and qualification.
Job Requirements
Education:
Bachelor level degree required, in a science or pharmaceutical sciences.
Experience:
From 6: 8 years of experience in a cGMP regulated environment,leadership experience required.
Skills/Competencies:
Proficiency in cGMP laboratory testing and major laboratory instrumentation.
Ability to interpret laboratory data and make sound compliance decisions based on such interpretations.
Excellent communication and interpersonal skills.
Excellent decision-making, problem solving, and analytical skills.
Detail-oriented with the ability to work under tight deadlines.
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.