QA

PANKAJ KUMAR PANDEY

Ph-+919*********/+919*********

mailto:*************@**********.***

C-99, Teva officer's colony mailto:**********@*****.**

Gajraula, Distt: Amroha (U.P)

PROFESSIONAL SYNOPSIS

Excel in regulatory activity by taking up challenging assignments at the

work place, hone skills by maintaining learning & leading attitude; proven

leadership skills by involving, managing, developing and motivating teams

to achieve their objectives. Dedicated to maintain high quality standard.

Able to work on own initiative and as part of a team. Constantly strive to

improve quality efficiency to enhance cGMP.

CARRIER ACCOMPLISHMENT

1. Sound knowledge of SAP system (SAP-R3 module), & also good hand in DCS

system.

2. Lead the Production team for Successful audit of KFDA, MHRA, TGA and

USFDA for manufacturing plants.

3. Nominated as a member on "Corporate Quality Management" Team.

4. Solved major problems, which temporarily halted production.

CURRENT CARRIER GRAPH

May 2012-Till now Teva India Ltd, Gajraula Officer-III,

Documentation &

Training

July 2011- May-2012 Unimark remedies Ltd, A'bad Executive

Documentation &

Training

July 2008- Feb 2011 Ranbaxy Laboratory Ltd, Dewas Sr.

officer Documentation &

Training

CORE COMPETENCY

Documentation

1. Logging the no. of the CCIF and tracking for compliances and closer.

2. Looking after vendor qualification.

3. Compliance of the regulatory by providing data to drug regulatory

department within the company.

4. Preparation, review and approval of validation and qualification

documents.

5. MPR firmed up based on the Process Package and control of executed BPR.

6. Equipment Qualification i.e. URS, DQ, IQ, OQ, PQ.

7. New SOP firmed up, revision of existing SOP and ensuring training of the

SOPs.

8. Handling of deviations (Planned and unplanned), investigation and

closer.

9. New product development, Scale up and validation activity.

10. Preparing the development report, product manual etc.

11. Handling of NCR for the RMs.

12. To co-ordinate the SAP team to update the SAP Recipe and SAP IPQC

recipe.

Training Documentation

1. Preparation of Master training need matrix.

2. Preparation of Departmental training need matrix.

3. Preparation of training calendar.

4. Scheduling of training as per job role.

5. Coordinating of training in our modules as per departmental training

need matrix.

6. Successful launch of training software SUM-TOTAL.

Production

1. Preparation of monthly production report.

2. Preparation of daily production report

3. Monthly Production Planning.

4. Raw material planning and execution on day to day basis and monthly

basis.

5. To co-ordinate with plant manager, QA, QC and maintenance manager for

the smooth working in the plant as per targeted schedule.

6. To arrange training within the plant for plant personnel as a trainee

coordinator.

Computer skill

MS word, Excel, PowerPoint, Data management system, BPR management system,

Track-wise, Documentation Compliance Manager, Dashboard, SAP, Sum-Total

(LMS) etc.

PREVIOUS WORK EXPERIENCE

Aug 2007- July 2008 Cadila Healthcare Ltd. Ankleshwar Officer

Production

July 2006- Aug. 2007 Lupin Ltd, Ankleshwar Officer

Production

July 2005- July 2006 Calyx chemicals & pharmaceuticals Officer

Production

Ltd. Tarapur (Boisar)

PROFESSIONAL QUALIFICATION

MBA

Vinayaka Mission Research foundation

Year of passing: - 2007

ACADEMICS CREDENTIALS

M.Sc. (Chemistry)

Magadh University, Bodhgaya

Year of passing: - 2005

TRAINING DURING JOB

1. cGMP Training session attended by Mr. Ron Johnson Ex-USFDA person

2. Team building by Mr. S. Nand.

PERSONAL MINUTES

Name : PANKAJ KUMAR PANDEY

Father's Name : SHREE HIRANAND PANDEY

Date of Birth : 5th October 1979

Nationality : Indian

Marital Status : Married

Current CTC : 4.0 Lac/annum

Other Activity

1. Always giving suggestion for compliance of GMP.

2. Always giving suggestion for tracking of CCIF, validations etc.

3. Always giving suggestion to for the reduction of costs and for the

improvement of yield.

Rational for Application

I feel that my sense of dedication will find an extreme fulfilment being

with your firm and help me to achieve my career objective with a

disciplined mind, as I have cherished.

Besides your firm also provides an opportunity to learn and has a better

working condition.

Place :

Date :

Pankaj Kumar Pandey

Contact this candidate