★Objective of hiring:

• Consulting to Hospira India on behalf of CAI Singapore, pertaining to Project Management of Greenfield project C&Q of a large injectable manufacturing facility at Vizag India.
• Working as PM-Commissioning & Qualification on behalf of CAI.
• Working closely with Jacobs US team and other reputed consulting companies.
• Reported to VP Asia operations (CAI) with a team size of 15.
• The facility was later successfully approved by the USFDA in year 2016.

★Challenges:
• C&Q of Large Solution Preparation System of batch size up to 11 KL.
• Introduced system level impact assessment & component level impact assessment.
• Introduced QRA (quality risk assessment) as per ICH Q9, along with Traceability Matrix.
• Handling CAPA and Deviation Management for the Large Solution Prep System.
• Handling Change Control during the Project Life Cycle.

★Key Accomplishments
• Implemented ASTM e-2500 approach in commissioning of Terminal Sterilization suite.
• Commissioned DELTA-V automation with support from SYNERTECH Singapore.
• Commissioned large Solution Prep. System of batch size up to 11 Kl.

★Impact:
Commissioning was performed using pre-approved protocols to ensure the design, use and performance of the equipment meet Good Engineering Practice (GEP) requirements. The commissioning tests were leveraged into the qualification based on investigation and approval. Qualification was performed using pre-approved protocols to verify critical aspects of system tested in commissioning using a trace matrix.