pankaj resume 16-12-14
TRANSCRIPT
PANKAJ KUMAR SINGHMobile: +91-8905188179 / 9998503922 / ~E-Mail: [email protected] / [email protected]
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