SUJEET KUMAR SINGH

Add: Vill - Vasudevpura, Lohgarh, Pinjore, Haryana, 134102

Contact: +91-9805980556, +91-9882229842;
Email: singhsujeet1783@gmail.com

QUALITY CONTROL - PHARMA INDUSTRY

Offering 15 years of experience; seeking challenging assignments across Pharmaceutical Industry

PROFILE
 Diligent & result-oriented Professional with a gratifying career span of 15 years predominantly in the
Pharma Sector in the areas of Planning and Review of FG/In process & Process Validation samples,
Investigations (OOS, OOT and Incidents) through Trackwise software, Trending of
OOS,OOT,Incident& Invalidation data, Team Leadership & Training.
 Successfully involved in various audits - USFDA, MHRA, Uganda, Tanzania, Kenya and TGA.

PROFESSIONAL EXPERIENCE
ALKEM LABORATORIES LIMITED, BADDI
Since 2th February 2012
Asst. Manager – Quality Control
 Responsible for the Planning and Review of FP/IP & Process Validation Samples.
 Preparation of Monthly & Yearly trend of OOS, Incidents, OOT and Invalidation data.
 To receive the instructions from the reporting authorities & follow them timely.
 To prepare the proposal data, risk assessment and related document etc. for reduced testing of
blend sample at in process stage.
 To plan and organize section activities & co-ordinate with other sections on day to day basis for
timely release of the samples.
 Responsible for the Planning and Review of Stability Samples.
 To ensure the timely withdrawal of stability sample from stability chamber as per planner.
 To ensure timely completion of stability sample analysis within window period.
 Preparation and Review of Stability data and summary report.
 To check & verify all the test reports & related documents and ensured compliance of GLP, and
accordingly inform to concern person.
 To prepare & submit the daily work report and pending work to the reporting authorities.
 To ensure timely Calibration and Validation of all Instruments used for analysis.
 To prepare daily report of approvals, rejection, under test and any other related work perform
during the day.
 To prepare & update protocols, method of analysis, specifications, SOP in consultation with reporting
authorities.
 Training of Supervisory and operating staff.
 To ensure that the analysis is conducted as per the approved STP or GTP.
 To ensure that the documentation done is online and error free.
 Compliance with cGMP requirement.

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SUJEET KUMAR SINGH
Add: Village - Vasudevpura, Lohgarh, Pinjore, Haryana, 134102
Contact: +91-9805980556, +91-9882229842;
Email: sujeet.singh@alkem.com, singhsujeet1783@gmail.com

 To ensure the calibration of Instruments timely as per SOP & also ensure that the instruments
are in operating condition.
 Monitoring records as per cGLP in QC.
 Practicing Good documentation practice in Quality Control department.
 Ensure the safety, health and hygiene in the QC department.
 To plan and manage the work in co-ordination with other departments.
 Train the employees in the respective areas/ procedure/ practices.
 To verify adequate availability of Columns and Chemicals for daily use & submit the requirement
accordingly.
 To release the finished products in SAP.
 Responsible for compliance of laboratory Investigations (OOS, OOT and Incidents, standards,
procedures and system, methods related to laboratory, testing, storage and release of the marketed
products.
 Review of Audit trail and data integrity assurance.
 Monitoring of quality management system (SOP, Change control, CAPAs and market complaints).
 Monitoring of Quality Management system for completeness of investigations to identify root cause,
existing controls available at site, Adequacy of proposed CAPA, and its effectiveness.
 Providing direction and guidance to the team with managing, motivating, coaching and mentoring.
 Release of products after complete review of certificate of analysis and review.
 HPLC System utilization on monthly basis.
 Preparation of audit reports.

PREVIOUS WORKING EXPERIENCE:

 Working with Cheminnova Pharmaceuticals. Ltd, Baddi as QC Chemist in RM section of quality
control department since May – 2006 to May – 2008.
 Working with INDOCO REMEDIES. Ltd, Baddi as QC OFFICER in Stability section of quality control
department since May – 2008 to Jan – 2009.
 Working with Dr.Reddys labs Ltd, Baddi as Junior Manager in RM section of quality control
department since Jan – 2009 to Jan – 2012.

INSTRUMENTS ATTENTIVENESS:
 HPLC: Waters with Empower-3 software, Agilent 1200 & 1260 series
 G.C: Agilent with Head Space.
 U.V: Shimadzu-1700.
 FTIR: Shimadzu
 Dissolution apparatus: Electro lab
 Polarimeter: Rudolph
 Karl Fischer Titrator (Metrhom & Mettler Toledo),
 DT apparatus: Electro lab

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SUJEET KUMAR SINGH
Add: Village - Vasudevpura, Lohgarh, Pinjore, Haryana, 134102
Contact: +91-9805980556, +91-9882229842;
Email: sujeet.singh@alkem.com, singhsujeet1783@gmail.com

Laboratory Software
 E-TMS (Electronic Training Management System) for training management in Quality control
laboratory. .
 E-DMS (Electronic document management system) for initiation and retrieval of document, SOP, STP
& Specs management.
 Trackwise (OOS, OOT, Incident, CAPA, Change control & CAPA effectiveness).
 LIMS (Laboratory information management system).
 Ariba Software (For procurement of Laboratory chemicals, standard & glassware etc).

EDUCATIONAL CREDENTIALS
 M.Sc. in Organic Chemistry (2006).

PERSONAL DOSSIER
Name : Sujeet Kumar Singh
Father’s Name : Shri Lal Sahab Singh
Date of Birth : 01/07/1983
Marital Status : Married
Languages Known : English, Hindi

DECLARATION:
I certify the above-mentioned information is true to the best of my knowledge and nothing has been
concealed. I have been always sincere and hardworking and would always work honestly for growth and
development of the organization.

(Sujeet Kumar Singh)

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