Quality Control Change

CURRICULUM VITAE

DHARMENDRA SINGH

M.Sc. (Pharmaceutical Chemistry)

Contact: +918*********

E -mail ID: ad8c2g@r.postjobfree.com

CAREER OBJECTIVE

A Pharmaceutical science seeking assignment in an organization which would utilize my skills to the full potential in the Pharmaceutical provide challenging opportunities with continued career growth.

PROFESSIONAL EXPERIENCE

Worked in Orikam Healthcare India Pvt. Ltd., Gurgaon (HR) in Quality Control Section as AQA Executive from (SEP/ 2022 to AUG/2024) in Dental Medicine & Injection and Devices Plant.

Worked in Mepro Pharmaceutical Pvt. Ltd., Savli, Vadodara (Gujarat) in Quality Control Department as QC Officer in Section AMV from (JAN/2022 to SEP/ 2022) in Injectable Plant.

Worked in Akums Drug & Pharmaceutical Pvt. Ltd. in Quality Control Department as QC Officer from (JUN/ 2018 to OCT/ 2022 ) in Stability Section in OSD & Injectable Plant.

Worked in Aishwarya Life sciences, Baddi ( H. P.) in Quality Control Department as Trainee QC Officer from (MAY/2016 to JUN/2018) in RM – Chemical Section in Injectable Plant.

Provided support in department planning activities.

Attended professional developmental seminars.

Conducted chemical research and documented findings.

Calibrated and troubleshot laboratory instruments.

Organized lab test solutions, compounds and reagents. INDUSTRIAL EXPERIENCE

Quantitative and Qualitative analysis of In-process, Raw materials and Finished products.

High-Performance Liquid Chromatography

UV/VIS Spectroscopy

Analytical Method Development

Prepared document of Method Development Protocol, Report Protocol like as Assay, Dissolution & Related Substance.

Investigation of OOS & OOT by QMS.

Perform stability studies on products.

Prepared report protocol of Stability documents.

Also prepared of STP, SOP and Specification of documents drug product and development.

ISO method validate and development in medical device instrument and preparation of in house requirement ISO test method.

CURRENT JOB PROFILE

Experience in QC/QA department work activity.

Handling of Deviation, Incident Change control, CAPA.

Issuance of Deviation, incident, Change control, CAPA form.

Ensuring the investigation are performed adequately in timely manner to identify the route cause Assess the impact & necessary CAPAs are initiated.

Review the investigation & ensuring the completion of investigation within timeline.

Preparation and approval of Quality control related documents (Standard Test Procedures, Specifications, Record of analysis for Finished, In process & Raw material analysis etc.).

Follow current Good Laboratory Practices and maintain documents accordingly.

Preparation and approval Specification & STP’s to respond Regulatory query.

Responsible for investigation of QC incidents.

Responsible for investigation and closure of all QMS events (OOS/OOT/incident).

Responsible for Change Control imitate and Closure.

Review of Analytical test data sheet.

Review of STP & Specifications.

Review of QC deviation.

Review of Stability Data.

INSTRUMENT HANDLING

HPLC

UV-Spectrophotometer

Dissolution Apparatus

Disintegration Apparatus

Calibration on HPLC & UV, RI, Viscosity meter or Weighing balance and pH meter and review of logbooks.

Refractive Index

Viscosity meter

IR

HIGHEST QUALIFICATION

M.Sc. (Pharmaceutical Chemistry) H.N.B. Garhwal

University,Uttrakhand

2015 1st Div.

B. Sc. (Chemistry) M.J.P. Rohilkhand

University, U.P.

2012 1st Div.

Computer knowledge MS Office, Excel, Word, PowerPoint, Operating system etc. SKILLS

Master of Science (Pharmaceutical Chemistry) from SBS. (PG)Institute (H.N.B.G.U.), Dehradun to make a winning career in the pharmaceutical industry.

Possess a flair for working hard and contributing towards achieve goals.

Endowed with a passion for winning as presented through proven excellence in academic

& extracurricular areas.

Capable to analyze and interpret unique problems, with a combination of training experience and logical thinking to find the right solutions.

Pleasing youthful personality with a zest for life, knowledge and sound understanding of tasks.

PERSONAL DETAILS

Full Name Mr. Dharmendra Singh

Father’s Name Mr. Rajveer Singh

Date of Birth 07 Jun. 1991

Sex / Marital Status Male/Married

Languages Known English & Hindi

Address

VPO- Heerawali, Nagina, Bijnor UP -

246762

EXTRA CURRICULAR ACTIVITIES

Worked as a coordinator in Management Program.

Active Participation in various Sports activities in college. PROJECT

Title: Evaluation of Natural dye extraction from Beta vulgaris by wool and medicinal herbs. TRAINING

Certificate of Training ISO/IEC 17025:2017 (General Requirement for the Competence of Testing and Calibration laboratories).

Certificate of Training ISO 13485:2016 (Quality Management System for Medical Device)

DECLARATION

I do here by confirm that the information given in this form is true to do the best of my knowledge and belief.

Place:

Date: Dharmendra Singh

Contact this candidate