Vijitendra Kumar P

Overhauled Operations & Team Leadership:

• Operational Oversight: Held first-line responsibility for In-Process, Semi-Finished, and Validation teams, overseeing daily operations, ensuring cGMP compliance, and driving quality standards across more than 9 years of pharmaceutical QC expertise.
• Market Complaint Management: Directed the full lifecycle of market complaints, including accurate logging, root-cause analysis, and detailed reporting to implement corrective actions, and improve Right-First-Time (RFT) metrics.
• Team Training and Development: Led on-the-job training programs for new analysts, providing hands-on guidance in HPLC analysis, SOP adherence, team processes, and analytical tools to accelerate onboarding and build high-performance teams.
• Validation & Equipment Qualification: Executed equipment qualification (IQ/OQ/PQ), routine sample testing, daily calibration reviews, and swab recovery qualification for IPQA, while facilitating cross-functional collaboration to enhance validation readiness and audit success.

Engineered Innovative Product Submissions:

• Regulatory Submissions: Spearheaded high-quality filings for emerging markets, securing approvals for critical lyophilized injectables, including Rifampin, Vancomycin, and Vecuronium Bromide, to combat infectious diseases and support surgical anesthesia.
• QC Analytical Support: Provided comprehensive analytical support for injectable portfolios such as Epinephrine, Bupivacaine, Fosaprepitant, Sugammadex, Succinylcholine, Lacosamide, Regadenoson, and Doxycycline, ensuring method validation, stability data generation, and compliance for emergency care, and anti-infective therapies.
• Specialized Product Filing: Drove successful submission of methylprednisolone injectable suspension, addressing global inflammation management needs through rigorous hold time studies, cleaning validation, and impurity profiling to meet international regulatory standards.

Conducted rigorous testing and method lifecycle management:

• HPLC Testing: Performed daily HPLC-based analysis of in-process and finished dosage forms to detect nonconformities early, ensuring consistent product quality.
• Method Lifecycle Management: Led the full lifecycle of Analytical Method Verification (AMV) and Analytical Method Transfer (AMT), including protocol development, execution, and reporting in compliance with ICH, USP, and cGMP standards.
• Cleaning validation: Directed analytical cleaning validation protocols for stainless steel, silicone, glass, and Teflon surfaces; executed three-run cycles with swab/rinse sampling using HPLC and TOC analysis.
• Hold Time Studies: Reviewed hold time sample protocols and confirmed regulatory submission requirements for product filings, ensuring readiness for audits and inspections. Hold Time Samples Analysis: Reviewed hold time sample protocols and confirmed regulatory submission requirements for product filings.

Revitalized Processes & Digital Efficiency:

• Documentation Streamlining: Revitalized product quality documentation processes, simplifying analytical reports, validation protocols, and batch records to enhance QC accuracy, reduce errors, and accelerate regulatory submissions.
• Digital Optimization: Implemented online calculation features in Empower and Chromeleon software, optimizing chromatographic data analysis for HPLC workflows, improving turnaround times, and boosting Right-First-Time (RFT) metrics in in-process and finished product testing.
• Performance Management: Set clear performance expectations for the team, monitored progress toward goals, and provided constructive feedback to drive accountability, and continuous improvement.
• Coaching and Development: Delivered targeted coaching sessions to build team members' skills, resulting in improved individual performance and stronger technical capabilities.
• Productivity Enhancement: Increased team efficiency by introducing streamlined work processes, and regularly reviewing performance metrics to sustain high productivity levels.

• Ensured daily validity of reagents, indicators, and volumetric solutions, and monthly identification and quarantine of near-expiry reference standards, primary standards, chemicals, and solvents.
• Oversaw the receipt, verification, and logging of in-process and S.F.G. samples in LIMS, and assigned A.R. numbers to miscellaneous, P.V., and hold-time samples.
• Monitored HPLC sequence completeness and managed the removal and storage of vials.
• Verified LIMS data and oversaw the removal, review, and destruction of leftover and expired samples.
• Assigned chemical tests in LIMS and issued samples for physical and wet analysis.
• Coordinated with production, quality assurance, and validation teams to plan analysis for process and cleaning validation samples.