VIKAS SINGH

A Pharma professional with M.sc (Chemistry) & 18+Years of valuable experiences in Corporate Quality Assurance, working as Manager - Corporate Quality Assurance in M/s Alkem Laboratories Ltd. Taloja, Navi Mumbai from September 2013 to till date.

• Audit and compliance expertise in the areas of Quality Control and Micro area for the API , Dosage forms like Tablet ,Capsules and External
• Audit and compliance of Due diligence sites and requalification/Caused based audits of different sites.
• Product/Project of the DMF/ANDA/DCGI documents evaluation and approval.
• QMS and Investigations
• Expertise and have knowledge working in Development Quality assurance and Central documentation cell
• Instrument and Software domain and working Knowledge like HPLC: Agilent 1100, 1200, 1260 Series, Waters alliance with PDA/UV detector and Shimadzu., GCHS: Perkin Elmer, Characterization instrument data: XRD, IR, UV, DSC, TGA.,
• Software Handled : Laboratory information management system software -LIMS, Trackwise, EDMS Software
• Basic Knowledge of SAP

• Responsible for the Audit of Analytical area and Quality management systems of different Vendor for the Drug substance, key starting materials and Drug products for the Loan License –Third Party Sites.
• Review of Vendor qualification data and Simplification of procedures on need basis in consultation with cross-functional teams.
• Review and evaluation of vendor compliance report related to Analytical areas.

• Responsible for audit of contract testing Laboratories (Outsourced Lab) and its compliance.
• Responsible for contract testing Laboratories (Outsourced Lab) Evaluation and finalization of technical agreements and its timely renewal.
• Responsible for overall compliance and handling of the outsourced Lab as per regulatory Requirement.

• 9892231287
• 8169316367

• CMO/ESO/Third party sites Audit and compliance, Loan License –Third party Product evaluation
• GMP & Document Management (Support in Audit of Internal and Vendor sites, PTL, KSM, Intermediates Audits)
• Quality Management System (Change Control, Out of Specification, Out of Trend, Laboratory Incidences and Deviation)
• Central documentation cell and Development Quality assurance.
• As per DMF and ANDA Submission requirement, documents evaluation.
• Accountable for inspection and readiness of In-house manufacturing sites, Loan License and Third party sites, Analytical Development Lab (R & D) with expertise in the Quality control, Quality assurance and Quality management system.
• Liaises with purchasing team for supplier specification and test methods and resolve Quality issue in case of dispute.
• Manage Analytical sub-contractors and ensure agreements and Audit is in place.
• Conduct pharmacopoeia reviews and review of other regulatory requirements and implement the changes.
• Change Control evaluation and its closure with respect to Specification and STP.
• Review of corporate quality assurance SOPs and Analytical development SOPs.
• Experience in Investigation of the failure, Plant issues related to analytical technique and Out of specification/Out of trends, Laboratory incidences.
• Expertise in review of Analytical method validation, Method transfer, Forced degradation activity for the Drug substance and Drug products.
• Coordination with cross-functional team across different sites (R&D, PDL, QA, DRA, Plant QA/QC etc.) for ensuring timely availability of specification and testing procedure and Change control closure for the same.
• Review and Approval of Specification and testing procedure of raw material, Excipient, In process, intermediate & API & Finish products.
• Sound knowledge of impurity profiling and fate/purge study of impurities from KSMs, Intermediate and Final API. In addition, awareness regarding Genotoxic Impurities and Nitrosamine impurities updation.
• Review of Process development report, Teck pack of drug substance, Qualification data and calibration data of equipment and Instrument.
• Expertise in Various Chromatographic software's like Empower, Chromeleon, etc. Additionally, handled electronic systems like Track wise, eDMS, LIMS (Sample handling and Analytical COA), SAP, eChange control.