PANKAJ KUMAR SINGHMobile: +91-8905188179 / 9998503922 / ~E-Mail: pankaj_indo@yahoo.co.in / gargaur_daman@rediffmail.com

JOB OBJECTIVE

Seeking senior level assignments in Quality Assurance & Control/ Regulatory Audit Compliance with an organisation of high repute in Pharmaceutical sector

PROFILE SUMMARY

• M.Sc. in Chemistry with over 10 years of rich & qualitative experience in Quality Control Operations, Process Enhancements & Client Servicing

• Currently associated with Macleods Pharmaceuticals Ltd., Daman as Assistant Manager - QC

• Skills in monitoring production operations for raw material and finished products and implementing systems for improving processes and enhancing operational efficiency

• Adept at managing the spectrum of activities encompassing Quality Management System, quality control and coordination with cross-functional departments

• Proficient in cGMP, and handling regulatory inspections such as USFDA, TGA, MHRA, WHO-GENEVA, ANVISA -Brazil, MCC – South Africa , INVIMA – Columbia and overseas customers like Ukraine, Taiwan, Indonesia, Libya & Tanzania

• Demonstrated excellence in ensuring compliance to quality measures by maintenance of appropriate documentation/ records

• Effective communicator with strong analytical and interpersonal skills

CORE COMPETENCIES

• Handling group as a group in charge and reporting to Sr.manager QC, trouble shooting on daily basis.

• Checking data integrity of analytical data as a section head

• Handling of Out of Specification, Out of Trend and Lab incidents

• Maintaining quality standards, norms & practices and identifying gaps & taking corrective actions

• Working in close coordination with work groups for conducting process audits and detailing on quality requirements

• Implementing latest systems, conducting internal audits and ensuring compliance to stringent regulatory requirements

• Training team members to focus on key deliverables for ensuring smooth flow of operations

• Ensuring calibrations and maintenance of laboratory instruments; scheduling predictive & breakdown maintenance jobs with key focus on spares availability & root cause analysis

• Troubleshooting all technical problems; conducting various tests & inspections to ensure that products developed are in compliance with pre-set quality specifications

• Assessing the customer feedback, evaluating areas of improvements & providing critical feedback on improvements

• Accountable for imparting Training to the new Employees Prior to access System also imparting the refresher training to the employees

• Deft at performing stability study, instrument qualification & preparation of SOP & STP related to quality control

ORGANISATIONAL EXPERIENCE

Since Dec’11 Macleods Pharmaceuticals Ltd., Daman as Assistant Manager QC Role:• Dealing with cGMP audits of WHO Geneva, USFDA, MHRA, Ukraine, MCC, etc.• Conducting Incident and OOS investigation while enforcing adherence to regulatory audit compliance • Planning day-to-day activities for finished product section• Executing review of Finished Product and Calibration Reports • Undertaking troubleshooting of HPLC• Verifying the calibration schedule

Dec’09 – Dec’11 Sun Pharmaceuticals Industries Ltd., Silvassa as Sr. Officer QC

Role:• Administered the entire gamut of functions inclusive of:

o Reviewing raw material & finished products reports o Conducting analysis of raw materials & finished products such as chemical & instrumentalo Managing calibration of instruments including HPLC, UV, DISSO, etc. o Handling LIMS (A Quick System for Online Testing Results)

• Entrusted with the addition OOS investigation and maintenance of calibration schedule Oct’07 – Dec’09 Indchemie Health Specialties Pvt. Ltd., Daman (Formulation Plant) (A Subsidiary Unit of Alkem

Laboratories Ltd). as QC Officer (Instrument Section)

Role:• Performed analysis of finished products and stability samples

Sep’05 - Jul’07 MAPRA Laboratory Pvt. Ltd. (A Group of M/s Aristo Pharmacuticals Pvt. Ltd.), Daman (Formulation Plant) as QC Chemist

Role:• Performed analysis of raw materials• Carried out preparations & standardization of volumetric solutions & reagents

Apr’04 – Sep’05 Aromatic & Industrial Pvt. Ltd., AmberNath Maharashtra (A MERCK under Taking Lab) - Analytical Division as a QC Chemist

Role:• Involved in sampling & analysis of raw materials

Instruments Handled:

• UPLC (water)• HPLC (Shimadzu, Dionex & Waters)• Atomic Absorption Spectrophotometer• Dissolution-Apparatus • UV/VIS-Spectrophotometer• FT-IR Spectrophotometer• Karl-Fischer Apparatus• Viscometer

EDUCATION

• M.Sc. (Chemistry) from J.R.N. Rajasthan Vidyapeeth University, Udaipur in 2005• B.Sc. from V.B.S. Purvanchal University, Jaunpur, Utter Pradesh in 2000

IT SKILLS

• Operating Systems: Windows 98 / 2000 / XP/7• Office Automation Tool: MS Office (Word, PowerPoint & Excel)

PERSONAL DETAILS

Date of Birth: 15th July 1979Present Address: Mr. Pankaj Kumar Singh, C/o Raju Bhai Patel, A3-204, Sarvaiya Appt., geeta nagar Vapi, Gujarat

PIN No: 396195

Permanent Address: S/o Sri Yashvant Singh, Village: Aurangabad, Post: Surhan, Dist. Azamgarh, Uttar Pradesh, PIN - 223224

Languages Known: English and Hindi