Deepak Kumar Email & Phone Number

Lucknow, Uttar Pradesh, India

• Documents preparation related to the QC department along with Medical Writing and coordinating with the DRA team for the approval of drug product submissions and other related requirements.• Write, edit, and review manuscripts, abstracts, dossier preparation, PSUR, Clinical and non-clinical research and study reports, and other medical documents to ensure accuracy, clarity, and scientific rigor.• Collaborate with multidisciplinary teams, including clinical, regulatory, and safety to ensure documents align with project objectives.• Ensure compliance with regulatory guidelines, ICH GCP, and other relevant regulations.• Conduct literature reviews to support regulatory submissions.

Lucknow, Uttar Pradesh, India

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Lucknow, Uttar Pradesh, India

Worked effectively with all kitchen personnel including technicians, and other staff members, and provided guidance along with overseeing product development procedures to identify any deviations from quality standards amendments of newly approved dishes.Worked regarding Food Safety Regulations and Perform Internal Audits.Devising, improving, and reviewing new specifications and procedures for products or processes, and training staff to use them.Setting the requirements for raw materials from suppliers and monitoring their compliance.Supervising inspectors, technicians, and other staff members and providing guidance.

Dahej, Gujarat

• Quality Control Investigation (Well-versed with QMS policies and handling OOS, OOT, Deviation, etc. to assist Manager QC.• Faced regulatory audits, and audits by State Drug Authorities.

Manesar, Haryana

• Chemical and Instrumental Analysis (Raw Materials, Finished Products, and Stability Samples).

Haridwar, Uttarakhand, India

• Chemical and Instrumental analysis of dosages forms (oral as well as injectables), R&D samples and maintaining their respective log books along with review and checking of all QC related records.• Preparation and execution of Analytical Method Validation, Cleaning Validation and Method transfer to and from other units/R&D along with the preparation of validation protocols and reports.• Preparation and review of RM, FP and PM specifications and testing procedures.

Kumrek, Sikkim

• Execution of Analytical Method Validation, and preparation of validation protocols and reports.

New Delhi Area, India

• Scheduling, arranging & approving of in-house as well as external party calibration of instruments & equipment’s.• Procuring all required Reference and Primary standards and preparation of their working standards along with all required chemicals and reagents.• Planning, scheduling, and handling of Analyst Qualification along with training programs on concern SOP’s and GAM’s.• Preparation and review of RM, FP and PM specifications and testing procedures.• Stability studies with documentation as per ICH-Guidelines along with the calibration of Walk-In-Type Stability Chambers and stability control room monitoring including planning for charge-in and withdrawn of samples as per protocol.• Handling of OOS, OOT, Deviation and Change control to assist the Manager.

Baddi

• Chemical and Instrumental Analysis (Raw Materials, Finished Products).