Quality Assurance Specialist

QA Senior Specialist

The QA Senior Specialist is responsible for providing quality assurance support within a pharmaceutical manufacturing environment. This role ensures that all quality activities related to products, processes, or systems, from raw material inspection to the shipment of the final product, comply with corporate and governmental regulations.

Responsibilities:

• Develop, coordinate, and execute Quality projects across multiple site QA areas.
• Collaborate with site QA planners to achieve project deliverables.
• Work with centralized functions to deploy global Pharma initiatives.
• Analyze, manage, and maintain data for cycle times, touch times, and tasks/process lists to optimize QA process performance.
• Drive the development, improvement, and maintenance of site QA planning and scheduling activities.
• Ensure QA areas under project scope implement and maintain visual management tools to monitor key QA processes.
• Analyze and report metrics for planned and unplanned activities for key QA processes, anticipating and identifying areas of risk, and mitigating risks through early risk assessments and implementation of fallback/mitigation strategies.
• Lead the development of the Project Charter and document requirements that satisfy stakeholders' needs and expectations. Establish project objectives and criteria for evaluating project results and activities of the project team.
• Support regulatory inspections for new market introductions.
• Lead or coordinate compliance and performance improvement projects, providing status updates to site management on assigned projects.
• Maintain effective liaison and cooperative relationships with Quality areas from Third Party Contractors (TPC).

Education Qualification:

• Bachelor's degree in a relevant field such as Quality Assurance, Pharmaceutical Sciences, or a related discipline.

Required Skills:

• Experience in manufacturing quality assurance.
• Experience with aseptic processes.
• Strong project management and coordination skills.
• Ability to analyze and optimize QA processes.
• Proficiency in data analysis and reporting.
• Strong communication and collaboration skills.
• Ability to lead and manage compliance and performance improvement projects.
• Experience with regulatory inspections and compliance.