Manish Kumar
Bijnor
Summary
My primary objective is to support the functioning of the organization by maintaining the data integrity, cGMP, ALCOA++, GDP & GLP. Managing staff, coordinating operations with QC Head and ensuring exceptional functioning of Quality. I aim to create a positive and productive work environment by communicating with team members, setting clear goals & monitoring performance.
Overview
2
2
Languages
5
5
years of post-secondary education
5
5
years of professional experience
Work History
Senior Officer
RUSAN PHARMA LTD.
Dehradun
07.2025 - Current
- Managed out-of-specification (OOS) cases through investigation, documentation, and implementation of change control, deviation, CAPA, QRM, and laboratory incident processes.
- Expertise in QMS activity: OOS, change control, deviation and laboratory incident.
- Respond to queries from DRA for respective regulatory submission as per ICH, TGA, ANVISA, PMDA,MHRA & cGMP guidelines.
- Coordinated training sessions on GLP compliance, enhancing staff knowledge and adherence to regulatory standards.
- Oversaw operations and maintenance of chromatography columns, ensuring optimal performance and compliance with regulatory requirements.
- Review electronic data/metadata, audit trail, GLP Compliance & Data integrity.
- Assisted auditors during visits and provided relevant information and documents.
- Developed various dosage forms including transdermal patches and nasal sprays.: Transdermal Patch, Nasal Spray, Parenteral, Oral liquid & Solid Dosage form
- Audit Accreditation: EUGMP, SHAPRA, ANVISA, TGA, Health Canada, Kenya, Ukraine
Sr. Officer
East African overseas
Selaqui
12.2024 - 07.2025
- Performed calibration of laboratory instruments to ensure precise measurements.
- Analyzed finished and stability samples by HPLC.
- Completed online documentation for extraneous peak, OOS, and OOT in compliance with MHRA and USFDA.
- To ensure proper documentation by all the concerned and all the documents as per current pharmaceutical regulatory requirement.
- To ensure proper documentation by all the concerned and all the documents as per current pharmaceutical regulatory requirements.
- Handled preparation of oral solid dosage forms in compliance with protocols.
- Conducted audits for EUGMP, PIC/S, and WHO-GMP accreditation to ensure compliance.
Officer
Skymap Pharmaceutical Pvt. Ltd.
Roorkee
11.2022 - 12.2024
- Analyzed RM, Finish, In-process & Stability samples using HPLC, GC & UV Spectrophotometer to support quality assurance.
- Managed inventory levels to ensure consistent availability of pharmaceutical products for timely distribution.
- Assisted in regulatory compliance by preparing documentation for audits.
- Prepared documentation for audits to assist in maintaining regulatory compliance.
Officer
Synokem Lifesciences Pvt. Ltd.
Haridwar
08.2021 - 09.2022
- Conducted analysis on raw materials, finished products, in-process samples, and stability samples using UV spectrophotometer.
- Executed chemical analysis on raw materials to ensure quality compliance.
- Conducted analysis of packing materials to ensure compliance with quality standards.
Education
Master of Science - Organic Chemistry
Mjpru University
Sehorha 07.2021 - 08.2023
Bachelor of Science - Organic Chemistry
Mjpru University
Dhampur 07.2018 - 07.2021
12th From Hindu Inter College
Kiratpur10th From Rana Singh Memorial Sikh Inter College
Amroha Skills
- Regulatory compliance
- Quality assurance
- SOP preparation
- QRM implementation
- Process improvement
- Continuous improvement
- Risk analysis
- Data analysis
- Analytical techniques
- Investigation management
- Document management
- Agile Mindset
Languages
- English
- Hindi
Instrument Skills
- English
- Hindi
Personal Information
- English
- Hindi
Disclaimer
- English
- Hindi
Languages
English
First Language
Hindi
Beginner
A1
Software Skills
- QAMS
- DMS
- Nichelon-5
- LIMS
- Empower 3.0
- Lab Solution
Timeline
Senior Officer
RUSAN PHARMA LTD.
07.2025 - Current
Sr. Officer
East African overseas
12.2024 - 07.2025
Officer
Skymap Pharmaceutical Pvt. Ltd.
11.2022 - 12.2024
Officer
Synokem Lifesciences Pvt. Ltd.
08.2021 - 09.2022
Master of Science - Organic Chemistry
Mjpru University
07.2021 - 08.2023
Bachelor of Science - Organic Chemistry
Mjpru University
07.2018 - 07.2021
12th From Hindu Inter College
10th From Rana Singh Memorial Sikh Inter College