Quality Assurance Management
Resume:
RAJESH KAPOOR
# ****, **** *****, *** *****, Sobha Amethyst, Kannamangla, Bangalore 560 067
Sl. No. Particulars Profile
* ********** **re than 18 years of experience :
Areas worked: Quality Control, Quality Assurance,
Production, Technical Affairs, Regulatory Affairs, FR&D and compliances
5 Companies Worked Group Pharmaceuticals Limited, Akums Drugs & Pharmaceuticals Limited, Micro Labs Limited,
Strides Arcolab Limited.
6 Audits Faced
(Formulations)
USFDA, MHRA, WHO GMP, PICS, Uganda, CIS
countries, ISO 9001:2008, ISO 13485, ISO 22716,
customer audits from GSK, Dr. Reddy’s, Abbott
7 Vendor Audits Carried
out for API /
Formulations manufacturing
Audits covering general cGMP systems and
Assessment of specified facility for Quality systems and Compliances to cGMP regulations, procedures
and policies.
Compliance Reference Documents followed are
WHO GMP, MHRA Guidance, ICHQ7, Q8, Q9,
Q1, Q4, Q5, Q6 requirements, USFDA
requirements, and project specific requirements.
8 Credentials Submission of Dossiers
Before time Query responses
Error free document review and approval for
Domestic and International markets
Validation team leader
Dental Products Development
ISO Auditor
9 Contact Detail Mobile: +91-973*******
10 Mail id acs20c@r.postjobfree.com
Professional Profile
Visionary and a goal oriented Senior Executive with demonstrated experience in planning, developing and implementation of solutions to address business opportunities. Develop strategic plans for product support, quality assurance, safety and regulatory affairs. Initiate and enforce strict budget controls addressing company needs and promotion of growth.
Adept at crisis management, trouble-shooting, problem-solving and negotiating. Experienced in planning, production scheduling and control, inventory management and budgeting.
Experience Summary
Handling audits of Bulk drug, formulation units, CMOs and CTLs. Total experience of 18+ years in the Pharma Industry and worked in different departments such as QC, QA, Technical Affairs, Regulatory Affairs, FR&D, AMD. Having experience in QC and QA for 16 years, Technical affairs & FRD 2 years, AMD 2 years, Heading Regulatory affairs 9 years.
Working as Associate Vice President Corporate QA & RA for Tablets, Toothpastes, Ointments, Liquid Externals & Liquid Orals manufacturing Units of Group Pharmaceuticals Limited India.
Worked as SGM Technical & Works for Group Pharmaceuticals Limited India. Worked as GM Corporate QA & RA for Group Pharmaceuticals Limited India. Worked as AGM Corporate QA for Akums Drugs & Pharmaceuticals Limited India. Worked as Officer in QC for Micro Labs Limited India. Worked from Trainee to Senior Executive in QC/QA for Strides Arcolab Limited, India. Areas of Expertise
QC/QA
Vendor Management
Regulatory Affairs
Budgeting
Training
Team building & leadership
Audit
Documentation
Achievements
Actively involved in obtaining the ISO 9001:2008, 22716, 13485 certifications. Active Participation in successful Regulatory Audits by MHRA, USFDA, WHO, PICs, Uganda and other customer audits.
Team building and ensuring a good work environment for the team. Competency building for the team to improve productivity. Return a 20% reduction in operational costs over one year. Efficient customer management.
Effective in meeting unit’s production target with weekly deliveries. Handled plant refurbishment project within time lines and budget New projects / pipeline submission vendor audits before time vendor audit close –out for all the products.
Conducted Trainings / Seminars at various CMO sites and Pharma Colleges. QA & RA Expertise
Meticulous review of SOP, as per QMS and facility related procedures. Implementation of QMS across the units (multi-facility) Monitoring and Tacking of QA Documentation
Monitoring of Control Samples and Archival systems In process QA activities
Vendor Audits
Documentation Management system
Support to inter / intra functional departments to resolve technical issues Support to manufacturing team to see compliances without any barriers Agency Audit interpretation of requirements
Facilitating Audit requirements
Handling of OOS, OOT, CAPA, Customer complaint investigations. All types of validation activity support
Carried out Gap analysis as per country specific requirements and supported the team for clearing the Audits ( UKRAINE / UGANDA / USA )
Review of harmonized specs with respect to IP/EP/BP/USP/IH. Fully conversant with Master Validation Plan, Site Master Plan, Validation Protocols, Market Compliance, Product and Recall procedures, Training Requirements. Change Controls, Self Inspections, and Deviation procedures. Preparation, Review & Approval of complete CTD files All types of variations, including change of ownership, change of Manufacturing sites and new indications.
Responding to queries from Regulatory Agencies
Gap analysis of the dossier already available and ensure that specifically it is reviewed and submitted as per country specific regulatory requirements. Review and Approve technology transfer documents.
Refresher/ Training modules to keep-up with latest trends in QA / RA. RAJESH KAPOOR
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