Rajesh Karasta
Senior Manager Operation Excellence-Quality, CQV & Microbiology Compliance | Ex-PQE Group | Ex - Akorn | Ex-Mylan | Ex- Macleods | Ex- Dr.Reddys
- Role
- Senior Manager at Curia
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Rajesh Karasta
Strategic, high-energy professional, successful in achieving business growth objectives…
Experience
Senior Manager
Aug 2024 — Present · Albuquerque, NM, US
Capturing of best practices and sharing it with site team and other site teams. Leading the Quality Compliance and Validation initiatives for computerized systems. Oversee CSV strategy, including SLC documentation review (URS, OQ, Risk Assessments, RTMs). Reviewing/approving SLC deliverables and ensuring alignment with GxP and 21 CFR Part 11. Supporting audit readiness, quality investigations, and process improvements. Mentoring junior quality team members in documentation and compliance practices. Coordination with Different Site Microbiology Team lead for smooth functioning of Laboratory. Training and Mentoring of team. Analysing the Operation Parameters and deviation occurrence during batch manufacturing and mitigating the same through the RFT Tools. To build culture of continuous improvement through coaching and mentoring of improvement projects. Setting up process of capturing OEE data and daily analysis of losses in Tier-1/2 meeting. Capturing of best practices and sharing it with site team and other site teams. Training of team members on LEAN SIX Sigma tools to build capability for problem solving and process improvements. Support the Site leadership team (SLT) in driving projects on Operational Efficiency improvement viz Capacity Enhancement, productivity improvement, Cost reduction, yield improvement, process capability etc. Analyzing various processes/applications using appropriate tools and recommending process improvement and enhance operational efficiency. Lead auditor for all internal and external audit. Conducting 20+ external audit and supported over more than 10 successful inspection. Responsible for review & approval of QMS document in Trackwise. Review and submission of compliance reports for audit observations. Ensuring 100% data integrity, reducing entry errors and improving test accuracy.
Education
Sikkim Manipal University, Gangtok
Master of Business Administration - MBA, Master in business administration
2012 — 2016
NIMS University Jaipur
Master's degree, Microbiology, General
2010 — 2012
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