Amanda Adams Email and Phone Number

Responsible for oversight of Process and Cleaning Validation, Aseptic Processing Simulations, CCIT, and Quality Engineering.

- Assisted with the development of the Process Validation program and associated Validation Plan and Standard Operating Procedures (SOPs) at Hospira’s green field site in Visakhapatnam- Organized and led cross functional meetings to ensure alignment between Manufacturing Science and Technology (MS&T), Production, Production Planning and Inventory Control (PPIC) and Process Validation for required batch sizes, solution hold time, bracketing strategies, and required development work to minimize impact to line time- Successfully executed the first Process Validation onsite and received FDA approval of the product- Provided reviews, input, and feedback on Technology Transfer documents for products being transferred to India from McPherson, KS and Rocky Mount, NC- Provided Subject Matter Expertise, Mentoring and training to the site on Process Validation

- Successfully planned, executed and completed the Process Validation (PV) for a new product, with an extremely aggressive timeline while minimizing product loss through effective scheduling- Assisted with the Alternate API Qualification Program- On-boarded new employees to the Process Validation group

- Redesigned the validation program for media fills (aseptic process simulations) and operator qualification- Managed the initial media qualification and bi-annual requalification of 7 aseptic fill lines - Participated in the consent decree remediation planning for process controls and media fills- Increased on-the-floor presence of validation to reduce deviations and provide support to manufacturing- Assisted with audits as a subject matter expert for media fills and CCI

- Managed daily production schedule for 22 production members across three filling & sealing lines.- Conducted batch record reviews- Organized maintenance activities and facility restarts