Associate Director, Validation - Rockville, United States - AstraZeneca
Description
What you'll do:
- Own and maintain a robust qualification and quality program to support and maintain a qualified and compliant state facility, including processes, laboratories, and utility equipment.
- Support Computerized System Validation (CSV) documents including Risk assessments, validation project plans, User Acceptance tests, and reports.
- Responsible for supporting/ leading investigation, implementation of corrective actions (CAPA), deviations, and change control for the GMP system.
- Support process and method transfer validation activities, as necessary by the manufacturing and Quality Controls lab.
- Be responsible for the Validation Master Plan (VMP) and guide the validation activities including validation maintenance studies, startup protocols, thermal studies, QC equipment, process equipment, and utilities.
- Lead a team of Validation engineers while actively handling personnel resources against active and forecasted projects.
- Assure that facilities, laboratory equipment, utility systems, and process equipment are maintained qualified/validated state and that reports are written accurately and timely.
- Direct daytoday operations of validation services in a way that minimizes downtime of manufacturing equipment.
- Author annual product quality review and ensure validation protocols and processes follow global regulatory requirements.
- Present overviews and defend site validation programs to regulatory and other agencies as necessary.
- Implement industry best practices to support site compliance operation and withstand inspection by regulatory agencies.
- Support implementation of product change requests and approve validation standard operating procedures.
- Responsible for preparing and handling within the annual budget and project coordination with AstraZeneca staff and/or outside consultants as necessary.
Minimum Qualifications:
- Bachelor's Degree. Life Sciences or Engineering Preferred.
- Minimum of 10 years experience in most of the following areas: FAT, SAT, and commissioning of facility systems
- Setting validation specifications for purchasing capital equipment or instruments
- Project management experience with upgrades and major construction projects
- Performing IQ/OQ on, Facilities/Utilities/Equipment Qualification, and Computer systems validation and Environmental Monitoring Performance Qualification
- Minimum of 3 years of leadership or management experience.
- Strong leadership skills with the ability to work in a dynamic environment and adapt their style to get along with all levels of management.
- Excellent project management and technical problemsolving skills. Must possess a passion for continuous improvement in accountable areas.
- Strong communication skills, both verbal and written.
- Knowledge of Lean best practices and cGMP.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines.
Why AstraZeneca?
With constant new products and launches, there's never been a better time to join Supply Chain and shape our future with a big contribution to life-changing medicines.
The challenge to stay ahead in rapidly changing markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients.
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