Enabling the process to facilitate the management at Board and Shop-Floor level to identify and help delivering strategic and transformational Quality leadership drive for imparting, Culture of Pharmaceutical Quality. Worked at global organisations across continents/ geographies to provide successful international growth initiative in Pharmaceutical, Bio-Pharmaceuticals, Herbal, Device, Healthcare, Cosmetics industry.
Mentoring, Training & handholding the site and corporate management to support and bring in the desired SOC – State of Control.
Click here to view PPT – CV of Udaykumar K. Rakibe
We have experience in on-site and off-site assessment of the GXP data. Provide effective compliance strategy and QIP (Quality Improvement Plan) for Quality Management. Services provided to various clientele- API- Intermediates, API/ DS, DF, Devices, IT- software, AI-ML. Since, March 2020; we adopted seamlessly to go virtual & did CGMP activities due to the exigency caused due to Covid-19 Pandemic. During subsequent Lockdown we provided the remote review & CGMP assessment for developed Markets like USFDA, EU region – QMS Review, Batch Record Review and Release of the Sterile Finish Products. Proposed the WL Remediation strategy, Plan and CAP. Virtual CGMP Audit and due diligence. Virtual Training and mentoring and advisory for Global corporations.
Click here to view PPT – Pharma Mantra Corporate PPT
