Dr. S. K. SINGH

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Ph. D. Chemistry with 25 years experience in Quality Assurance & Quality Control(Tablets, Capsules, Liquid Orals, Ointments, Small Volume Parenterals, Dry Syrups,Herbal preparation & Stability Studies) at Senior Management level with reputed companies as per WHO-GMP/ISO 9001:2008,Schedule M, Schedule L1 & Schedule T .

Contact Details

Dr. S.K. Singh
401, Kanti Height,Om Nagar Ambadi Road, Vasai (W) Dist : Palghar, 401202

+91 9099004723
+91 9158840329
E-mail: drsingh906@gmail.com


About Me

An astute leader with over 25 years of industrial experience in Pharma formulation plant:
- Quality Assurance & Quality Control
- Stability Studies
- Validations - Regulatory Affairs
- Quality Compliance
- Training

Stability studies of Drug products & Drug Substances as per regulatory / customer requirements.
Extensive experience in conceptualizing & implementing quality systems & Quality compliance as per regulatory requirements. Extensive experience in all aspects of quality control & quality assurance of various processes & finished product. Proficient in developing & streamlining systems with proven ability to enhance operational effectiveness and meet operational goals within the cost, time & quality parameters.


EDUCATION

Degree
Ph. D (Chemistry) • June 2009
VBS Purvanchal University, Jaunpur (UP)

School & College
M.Sc. (Organic Chemistry) • 1988 - VBS Purvanchal University, Jaunpur (UP)
B. Sc. (Chemistry, Botany & Zoology) • 1986 - Gorakhpur University (UP)
Intermediate • 1984 - Allahabad Board, Uttar Pradesh
High School • 1981 - Allahabad Board, Uttar Pradesh



WORK EXPERIENCE

Analysis
◊ Raw material, finished products, in process test, packing materials & Stability samples.
◊ Review & approvals of technical documents including test protocols & test reports.
◊ Issue and review of batch manufacturing & Batch packing records.
◊ Release of pharmaceuticals product for sale.
◊ Work allocation & work supervision.
◊ Documents issuance & Documents control.

Validations
- Process Validation.
- Analytical Method validation.
- Cleaning validation.
- Water System validation.
- URS, DQ, IQ, OQ & PQ.
- Personnel Validation.

Others
◊ Research Stability Studies (RSS).
◊ Annual Product review.
◊ Handling of Technical Complaints.
◊ Handling of visitors (Regulatory bodies/ international auditors/ customers).
◊ Authorisation of artworks.
◊ Technical supports to Regulatory & marketing team.
◊ Self Inspection.
◊ Management Representative for ISO functions.
◊ Risk Assessment.
◊ Training & to identify the needs of Training (TNI).
◊ Inspection & Approval of Third Party / Contract Manufacturing/Analysis.
◊ Handling of Technical Complaint.
◊ Change control & Deviation Control.
◊ Investigation of “Out Of Specifications” (OOS) & Out Of Trend (OOT).
◊ Review of BMR & Batch Release.
◊ Authorisation of stability Reports / Stability data & Analytical reports.
◊ To Arrange medical camp for routine medical check up & Cancer detection test for the employee.
◊ Implementation of Quality Management System as per ISO/IC 17025 & Schedule M


AUDITS FACED

WHO-GMP, MOH-Kenya, NAFDAC-Nigeria
PDB-Ghana, MOH-Ukraine, MOH-Tanzania
NDA-Uganda, FDA-Nepal, MHRA-Zimbabwe
MOH-Malawi, State Pharmaceuticals Corporation (SPC) Sri lanka,
MOH Iraq, State GMP & ISO 9001:2008 & NABL.