PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Identify, obtain or create a development report as related to qualification that outlines the approach and Validation justification/ rationale, and include existing reports from the site.
- Plan and lead qualification program in collaboration with Site Quality, Operations, and Technology.
- Provide technical expertise to the Validation Department for the creation of equipment protocols.
- Work in conjunction with Technology Transfer, Engineering and Maintenance Departments to provide technical support to manufacturing, to ensure that manufacturing equipment is qualified and maintained in a current state of requalification, and resolution of problems/issues concerning compliance and equipment.
- Manage the execution of Validation programs to demonstrate the qualification of the manufacturing facility, utilities and equipment as applicable.
- Work with the organization for the resolution of problems concerning qualification issues and product disposition.
- Prepare and defend qualification strategy to regulatory agencies.
- Assist in the development of qualification protocols and reports.
- Provide resources and technical expertise in meeting compliance commitments and in the resolution of investigations to determine product disposition as applicable.
- Ensure that system preparation and qualification meet cGMP’s and company compliance standards as well as and industry expectations.
- Assist project teams in the assessment of business factors including: quality, cost, capacity, facility/equipment capabilities, schedule and regulatory requirements.
- Recommends changes in policies and procedures, to management, to enhance the company’s ability to conform to directives and regulations.
- Adhere to site safety standards, participate in the routine safety training events, and enforce safety/chemical hygiene requirements as they relate to the Department.
- Ensure the department adheres to cGMP requirements and is fully trained in relevant policies and procedures.
- Ensure that Validation Department conducts in accordance with current Good Manufacturing Practices, the company’s quality goals and sustainable compliance initiatives, as well as the company’s mission, vision and values.
- Lead the department staff to fully utilize and develop their skills in the area of equipment qualification (new and requalification), through a program that includes attendance at technical seminars and/ or on the job training.
- Working within corporate guidelines to ensure that staff are trained in and practice applicable safety, loss prevention, environmental controls and regulatory requirements in their day to day work habits.
- Collaborates with the Environmental Management System Representative for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
- Collaborates with the Energy Management System Representative for ensuring that Energy Management Requirements are met under ISO 50001 standards.
- Collaborates with the Occupational Health and Safety Management Representative for ensuring compliance to Occupational Health and Safety is met under ISO 45001.
- B.S. degree in Engineering or related field with a minimum of ten years directly applicable experience.
- Must have experience in computers, high mathematics (i.e., calculus and/or statistics), and technical writing.
- Must have excellent computer software usage skills including, but not limited to MS Word, MS Excel, MS Project and MS Access.
- Must have excellent knowledge of mechanical equipment engineering and functional testing.