Manoj Kumar Email & Phone Number

Bengaluru, Ka, In

Derra Bassi (Sas Nagar)

• Quality Management Oversight: Responsible for the quality review of deviations, change control, incidents, OOS, OOT, CAPA management, and risk assessments, ensuring compliance with QMS activities.• Team Leadership: Led a team of 8 members, managing daily work allocations for reviewing laboratory QA data and audit trails in accordance with 21 CFR and standalone systems.• Audit Participation: Independently faced USFDA and other audits, specifically focusing on the Quality Lab and Compliance sections, ensuring readiness and compliance during inspections.• KPI Management: Maintained control over all KPIs and took appropriate actions to align with management expectations, driving continuous improvement in quality metrics.• Training & Cross-functional Collaboration: Conducted training on QMS tools for factory personnel as a certified trainer and participated in cross-functional team meetings to identify risks, exchange information, and track progress on new projects.

Sas Nagar, Punjab, India

• GMP Compliance & Testing Accuracy: Conducted 1,500+ tests annually with a 98% accuracy rate, ensuring product safety and GMP compliance.• Method Validation & Project Timelines: Validated and transferred 100+ methods, contributing to reduced project timelines and efficient ANDA batch execution.• Regulatory Compliance & Instrument Management: Maintained FDA, EMA, and pharmacopeial compliance over 7 years; managed 150+ instruments to minimize downtime and improve productivity.• Data Integrity & Lean Practices: Ensured data integrity, reduced audit findings, and implemented lean lab practices, increasing efficiency and reducing errors.• Cross-functional Collaboration & Project Leadership: Led cross-functional meetings and quality initiatives (21st Century Quality), presented key data in Quality Review Boards, and supported projects like LIMS and LabX at the plant level.

Baddi, Himachal Pradesh, India

• Management of Trend process for critical quality attributes and critical process parameters for Raw materials and finished products. (Six sigma).• Analysis of Stability product samples,Perform Dilution study.• Review of Standard operating procedures related to quality control department.• Perform internal audits with respect to cGMP norms and breach in data integrity across various function of organization.

Baddi, Himachal Pradesh, India

• Preparation of Specifications and STPs against Pharmacopoeia.• Preparation of Master stability Protocol.• Preparation of Re-qualification Protocol of Instruments.• Protocol preparation of Analytical method validation, cleaning method validation.• Analysis of Stability, IP/Finished Product Samples.

Puducherry, India

• Planning and execution of Quality Control samples.• Leading a five member team for process validation sample testing.• Protocol preparation of Analytical method validation, cleaning method validation.• Preparation of SOPs, Specification, Test Procedure etc.

Baddi, Himachal Pradesh, India

• Preparation of Method transfer/validation protocols and reports.• Method transfer From API and Formulations Units as well as from other External agencies.• Method Verification/Equivalence for Pharmacopoeia changes.• Preparation and Execution of Master Schedule of Calibration and Performance.• Performance Verification's & Calibration of all instruments and equipments used in Quality control operations.• Analysis of In-process, Finished Product & Stability Samples. • Operated High & Ultra Pressure liquid Chromatography (HPLC & UPLC), Gas chromatography,Dissolution tester and other analytical instruments.

Master Of Science (M.Sc.), Chemistry, First

Bachelor'S Degree, Chemistry, First