Quality Control Assistant Manager

CURRICULUM VITAE

SUNIL KUMAR Phone:*********

M.Sc. (Pharmaceutical Chemistry)

E-mail: ******.*************@*****.*** Page No. 1 of 5

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OBJECTIVE:

Specialist in Quality Control, who can make qualitative difference, with an esteemed organization, where high competence & skill is rewarded equally for the mutual benefit of the organization & self.

TARGET JOB:

INDUSTRIAL: Pharmaceuticals oral solid dosage.

CAREER LEVEL: Quality Control post.

Description Of My Perfect Job: An organization that provides ongoing personal development. It is important to have a stimulating workplace, and to keep progressing as an organization.

Mar. 2018 to till date

Employee of ZYDUS CADILA HEALTHCARE SEZ AHMEDABAD (Gujarat) working as Associate Manager in Quality Control & handling Finish Product / In-Process section.

Jul. 2017 to Mar. 2018

Employee of MACLEOD PHARMACEUTICAL INDUSTRIES LTD., BADDI (H.P.)

Worked as Executive QC (Stability Section).

Nov. 2008 to Jul. 2017

Employee of CIPLA PHARMACEUTICAL LTD. BADDI (H.P.) worked as Officer to Assistant Manager designation in QC (Finish Product, In-Process, Interim Control Section and Chromatographic Section)

INSTRUMENT HANDLED: Handled all the Critical Laboratory Instruments;

Dissolution apparatus.

U.V.Spectrophotometer

K.F titrator.

D.T. Apparatus.

Polarimeter.

X-RAY SPECTROPHOTOMETER

IR Spectrophotometer.

PARTICAL SIZE ANALYSER.

HANSON MEDIA PREPARATOR.

D.O. METER and pH meter.

MELTING PIONT APPARATUS.

HPLC Agilent 1100, 1200 & 1260series with Chromeleon 6.8 & 7.2 Software

HPLC Dionex ultimate 3000 with Chromeleon 6.8 & 7.2 Software.

HPLC SHIMAJU LC 2010 WITH Chromeleon Software.

Weighing Balance

LC-MS Instrument

ACADEMIC QUALIFICATION:

Academic Qualification

Board

M. Sc. (Pharmaceutical Chemistry)

HNB GARHWAL UNIVERSITY UTTARAKHAND

B. Sc. (PCB)

H.P. UNIVERSITY SHIMLA

10+2 (MEDICAL)

H. P. BOARD OF SCHOOL EDUCATION DHARMSALA

MATRICULATION

H. P. BOARD OF SCHOOL EDUCATION DHARMSALA

COMPUTER KNOWLEDGE:

MS Office (MS Word, MS Excel, MS Power Point) with good typing speed.

COMPUTERIZED SOFTWARE HANDLED:

LIMS 3.2.0 {Caliber} (Sample Manager, Resource manager and System manager)

LIMS 3.4 (Sample Manager, Resource manager and System manager).

Trackwise {QMS}: (To handle Planned & Unplanned deviations, OOS, OOT, Incident Investigation, CAPA )

Chromeleon 6.8 & 7.2 with electronic signature with online calculation.

AUDIT FACED:

WHO Geneva Audit Faced in Cipla Pharmaceutical Ltd.

TGA Audit Faced in Cipla Pharmaceutical Ltd.

USFDA Audit Faced in Macieods Pharmaceutical (14 Nov.2017 to 24 Nov.2017)

USFDA Audit Faced in Zydus Cadila Healthcare (25 March to 4 April 2019)

USFDA Audit Faced in Zydus Cadila Healthcare (20 March to 24 March 2023)

RESPONSIBILITIES HANDLED:

AT ZYDUS CADILA HEALTHCARE SEZ MATODA AHMEDABAD

Q.C. Reviewer For Finished Product / In-Process/ PV/Stability Samples.

Key Result Areas:-

Effectively handling of Finish section 19 members team work allocation (16 Analysts and 3 Reviewers) with maximum instrument Utilization for maximum Finished Products Release.

Ensuring all analyst activities during the analysis of allocated work as per Good-Laboratory Practices laid down in the Quality Control Procedures and STP, online reporting in LIMS software in respective shift.

Daily check the validities of chemicals, working standards and due date of instruments, equipments calibration.

To ensure adequate identification and segregation of test samples to avoid mix up and cross contamination

Handling & troubleshooting of all sophisticated instruments eg. H.P.L.C., XRD, UV- Spectrophotometer, Dissolution, Karl Fisher instrument, LC-MS etc.

Managing QMS activity on Trackwise software like:- OOS, OOT, Lab incidents, Change Control, Deviation CAPA etc.

Responsible for internal and external (Regulatory) audits.

Responsible for maintaining GLP & GDP, Lab compliance

Documenting & reviewing Specification, SOPs, Review of Test Data Sheet, Analytical Test Report & Masters

Interpreting data for conformance to procedures, standards and protocols and/or real- time recognition of aberrant data and results.

Investigation and support in the Market complaint.

Rendering technical support to the analyst & Quality Control Head.

Complying with the regulatory requirements including GLP & USFDA.

Providing Training & Development to the reviewers and analysts assigned to the department.

Creating goals, objectives and measures to drive continuous improvement of the QC operations.

Organizing training on new SOP and also providing ongoing technical training.

Review of data for integrity.

Participate and lead investigation, project and improvement teams. Support department goals and objectives.

Lead root cause investigations. Link to solutions and prevention.

Responsible for preparation of experiment plan during investigation.

Responsible for implementing the CAPA Parameters after investigation.

To check the effectiveness of CAPA.

Coordinate & present all relevant documents to external auditors and to ensure that corrective measures are taken on any non-compliance finding.

Participates on quality system project teams; supports development, effective implementation, continued maintenance, and ensures compliance is achieved and standards are met.

Highlights:

Played a key role in improving quality by taking initiatives.

Completed quality projects within time by proper planning & execution of planning.

Reduced the failure through measures such as GAP analysis & then CAPA to remove the GAP e.g. display of key activity in each area for better understanding, Display of do’s & don’ts in respective area etc.

Reduced Invalid OOS & OOT by supervising & mentoring the team, and streamlining activities.

Played a key role for the development and establishment of the documentation activity.

Initiated the concept of performing the outside testing within the laboratory, Teach teams on process and critical thinking skills to develop shared vision for solutions and improvements.

Prepared and evaluate trends in quality system to monitor effectiveness. Utilize statistical methods for analysis. Develop metrics to support quality goals and objectives.

Perform risk based analysis using quality, compliance and business needs. Adjust required actions as per the risk involved.

DEPARTMENT SPECIFIC/ON-GOING FUNCTIONS:

Provide timely reports to LIMS for recording of results.

Keep all documents adequately filled and updated.

To plan and organize the daily working schedule of QC team.

To participate in self-audit.

Develop a high performance work environment to build a capable and motivated team within QC function.

Ensure technical development of QC resources, systems and processes to drive long term sustainable quality as well as efficiency

Plan out all QC resources and activities in relation to company objectives and set targets.

Fulfill objectives of the management team.

AT MACLEOD PHARMACEUTICAL INDUSTRIES LTD., BADDI (H.P.)

Stability Section Executive Designation:- Job Responsibilities

Effectively handling of Stability section of 6 members team with maximum productivity.

HPLC Data processing and Review the Reports of stability section.

Handling & troubleshooting of all sophisticated instruments eg. HPLC, UV- Spectrophotometer, Dissolution etc.

Daily check all the instrument and equipment usage log books, validities of chemicals, working standards and due date of instruments calibration.

Maximum utilization of instruments by effectively planning

Training of analysis in Laboratory techniques, Quality control procedure and principles of Good Laboratory Practices, General analytical methods and instrumentation.

Monitoring & support to junior staff during analysis and also training on Data-integrity, good documentation practices and good laboratory practices.

Responsible for maintaining GLP & GDP, Lab compliance

Handling of Incidence, OOS and OOT.

Column storage with great care by which increase the life period and cost saving.

AT CIPLA PHARMACEUTICAL LTD BADDI (H.P.)

From 2015 to 2017 as Finished products section Reviwer in Cipla,Baddi.

Job Responsibility:-

Review the Reports of different section in laboratories.

Planning of Finished products samples in the absence of section head.

Ensure the work within the written procedure.

Review the chromatography sequences as well as data.

Filing the incidence,OOS and OOT,involved in investigation as well as compilation of investigation reports.

Ensure the Reports template verification and its use in chromatography section

Monitoring effective functioning of QC analysis in section, online review and compliance of reports.

From 2008 to 2015 as Analyst in Cipla,Baddi.

Job Responsibility:-

Analysis of Finished products and in-process samples as per procedure.

PERSONAL DETAILS:

FATHER’S NAME

Sh. Bishan Singh

SEX

Male

LANGUAGES KNOWN:

English, Hindi.

MARITAL STATUS

Married

DATE OF BIRTH

29/02/1984

DOMICILE

Himachal Pradesh

ADDRESS FOR CORRESPONDENCE

S/o Sh. Bishan Singh

Village Bhatoli P.O.-Malyawar, Distt - Bilaspur, (H.P.)

Declaration:

I hereby declared that the information given above is true to the best of my knowledge & belief and no data has been concealed or distorted.

Place: Ahmedabad

Date: 23/04/2024 (SUNIL KUMAR)

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