Kalidhass Balasubramanian Email & Phone Number

Profile • Quality Assurance professional in the pharmaceutical field with experience in Quality Assurance, Regulatory compliance and Quality control.• Hands on experience in building QA systems and regulatory requirements. • Actively participated & supported in regulatory audits.Professional Expertise• Handled Pharmaceuticals and Biopharmaceuticals projects and played a project team leader role for a NCE project.• Hands on experience in setting up the quality systems at R&D and commercial environment supporting the drug development process at different stages starting from early development stage, clinical studies stage, registration stage and commercialization stage.• Hands on experience in Implementing the Quality by Design(QbD) process and Quality Risk Management(QRM) tools in the drug development phase.• Effective team player and successfully integrated with the cross functional teams including Regulatory CMC, R&D team, CRO/CMO and supply chain.• Audit experience across various domains like API, Drug product manufacturing, excipient manufacturing sites and analytical testing service provider.• Lead the regulatory compliance team and ensured the accuracy of CMC documents like Analytical method validation, Batch records and Batch analytical documents etc. Wide experience in handling regulatory audits and the CMC queries.• Experience in managing quality control laboratory and stability studies function.• Strong interpersonal skills to Lead and Mentor the team members.• Excellent interpersonal skills with ability to communicate effectively with individuals/to groups and to coordinate with cross functional teams.

Listed skills include Gmp, Regulatory Affairs, Glp, Pharmaceutical Industry, and 28 others.