Vikrant Singh Parmar

Biography

  Experience Quality Compliance Manager Company NameAkorn, Inc Dates EmployedDec 2015 – Present   Employment Duration1 yr 10 mos LocationPoanta Sahib Quality Compliance Manager Company NameAkorn Pharmaceutical Dates EmployedDec 2015 – Present   Employment Duration1 yr 10 mos LocationIndia ,Paonta Sahib Quality Compliance Manager Company NameSUN PHARMA Dates EmployedJan 2015 – Dec 2015   Employment Duration12 mos LocationChandigarh Area, India • Accountable for assessing and assuring process compliance at manufacturing site of the company. • Executive and monitor remediation compliance, and key compliance policy actions to drive business decisions. • Evaluate and report compliance status of manufacturing site to Head – Compliance of Region on periodic basis. • Ensure that employees comply with company requirements and the laws and regulations of regulatory agencies. • Serves as independent and objective function for the review and evaluation of compliance/ethics issues and concerns at the manufacturing site. • Ensure compliance of respective units from their functions on a routine basis according to established policies and processes. • Review compliance standards via policies and procedures, training, auditing and monitoring. • Support that help to ensure that employee behaviour in the organisation meets the company’s Standards of Conduct, including review and monitoring programs designed to improve the quality culture. • Monitors the compliance efforts of the site and provides suggestions on compliance-related matters to site functional heads and Head – Compliance of Region. • Member of Site Compliance Committee to report / evaluate compliance. • Coordinate and support to major health authority inspections at site and provide input and review of inspection responses to drive consistency and clarity. • Perform and document regulatory compliance assessment in accordance with established compliance plans, regulatory commitments and the standards defined in the Company Quality Manual / national and international cGxP and statutory requirements. • Execute lessons learned, KPI and trend reports resulting from cGxP inspections and assessments to assure on-going sustainable compliance from development to shop floor to lifecycle management of products and processes. Assistant Manager QA compliance Company NameTorrent Pharmaceuticals Ltd Dates EmployedJun 2014 – Jan 2015   Employment Duration8 mos LocationBaddi GMP/GLP internal audits, Deviations Investigation, Incidents, Change controls, Out of specifications investigations, Out of trend investigations, CAPA Tracking and contract lab audits. The Complete activity of Quality compliance during major regulatory Audits. Audit preparedness. To give training to face the regulatory audit. Excellent interpersonal, communication, managerial and organizational skills. Wide exposure in compliance assurance and verification, quality management system, regulatory submissions and query responses, project management, regulatory audits & response, contract lab audits and technical training. .   Assistant Manager QA Company NameFresenius Kabi Dates EmployedAug 2010 – Jun 2014   Employment Duration3 yrs 11 mos  Well versely handled GMP/GLP audits, Deviations, Incidents, change controls, out of specifications, Out of trend CAPA and contract lab audits.  Maintain technical bridge between I&D (RA,AD and F&D) and Manufacturing unit.   Preparation and review of Stability Trends, Stability Protocols and reports and management/Planning of stability analytical studies.  Preparation and review of documents related to Technology transfer for new projects.  Efficiently provided necessary support in terms of review and collation of CMC/Quality data for Preparation and submission of applications/dossiers for US, EU, ROW and Japan.  Ensured maintenance of all applications/licenses at manufacturing locations by monitoring and maintaining all formulation, drug product listings and registrations and Submission of annual reports.  Preparation and review of SOP’s, specifications and test procedures.  Review of Analytical reports, Batch records, Process Validation and method transfer protocol reports.  Preparation and review of Quality Risk assessment documents for systems & processes  Review of batch size calculation sheets, New projects cost calculation and other execution   Document control by issuance, retrieval, storage and destruction.  Art Work review.  Responsible for Batch release as per the specific regulatory requirements.  Stability data evaluation to understand the trend since from the beginning and to alert the technical team in case of any fluctuation/out of trend result observed and Review the Stability Protocol for its Regulatory Compliance.  Response to Queries raised by different regulatory agency/MOH within the stipulated time period.  Preparation review and execution of Qualification and calibration protocols of various quality control instruments including Gas chromatograph, high pressure liquid chromatographs, spectrophotometers etc.   Expertise in the operation and calibration of various quality control instruments.  JR. MANAGER Company NameDR.REDDYS LAB Dates EmployedSep 2006 – Aug 2010   Employment Duration4 yrs  Stability data evaluation to understand the trend since from the beginning and to alert the technical team in case of any fluctuation/out of trend result observed and reviews the Stability Protocol for its Regulatory Compliance.  Stability Studies and its execution in QC lab and other additional studies at contract lab and handled team of 22 analysts.   Preparation and review of Stability Trends, Stability Protocols and reports and management/Planning of stability analytical studies.  Preparation review and execution of Qualification and calibration protocols of various quality control instruments including Gas chromatograph, high pressure liquid chromatographs, spectrophotometers etc.   Expertise in the operation and calibration of various quality control instruments. Lab Chemist Company NameInd-Swift Limited Dates EmployedJan 2006 – Sep 2006   Employment Duration9 mos LocationDerabassi Worked as aLab chemist Responsible for finished product analysis. Trainings, Responsible for sampling activities Audit preparedness

Research Interest

 Over 12 years of cGMP regulated environment experience holding positions of increased responsibility within the Quality Control, Quality Assurance and Quality compliance Teams. Demonstrated knowledge of regulatory requirements and international standards (e.g. US CFR Title 21 Parts 11,210,211,600,606,610,820; EudraLex Vol. 4, ICH Q9 and QJ0). Professional with strong work ethic, integrity that holds others and self-accountable. Proven track record of driving results independently and through cross-functional teams to improve communication, address compliance gaps and eliminate waste. Expertise in creative problem-solving through innovation and technology. Strong research, analysis, interpersonal and technical writing skills. Diverse background and skill-set with emphasis in critical and analytical thinking, decision making, negotiation, employee empowerment and interpersonal communication. Diverse exposure in External and internal audit compliance, Data integrity aspects and implementation, Quality system remediation, verification concept, quality management system, regulatory submissions and query responses, project management, contract lab audits and technical training.