Quality oversight for the execution of Facility, Utility, Equipment, and Process systems.
Work closely with all departments for Operational Quality to ensure the operation of validated environments and production processes according to GMP and other regulatory requirements.
Establish and maintain validation master plans for new and existing projects in support of cGMP requirements.
Continue to develop and improve the in-house validation strategy and operational quality processes.
Provide technical assessments on change control, deviation, and investigation from both validation and in-process quality perspectives.
Assess proposed changes to validated processes and production operations to identify requirements necessary to maintain validated and compliant status.
Oversee in-process quality control, batch record review, line clearance, and process verification to ensure consistent product quality.
Participate in internal and external audits, inspection preparation, and response activities.
Serve as Subject Matter Expert (SME) for qualification, validation, and operational quality-related topics.
Collaborate with manufacturing, engineering, and quality units to resolve production or validation-related issues and support continuous improvement initiatives.
Responsibilities:
Demonstrate flexibility in problem-solving, providing risk-based options towards challenges for Management review and decision-making
Independent decision-making capability and ability to think conceptually and understand impact of decisions critical to product quality
Ability to influence, develop, motivate and empower employees to achieve objectives with a team approach
Demonstrate initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision
Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the organization
