Summary
Overview
Work History
Education
Skills
Certification
Software Skills
Timeline
Generic
PAVAN SHAH

PAVAN SHAH

Summary

Proven leader in food safety and quality management, excelling in GMP and HACCP protocols at Advice Chaser. Demonstrated expertise in enhancing product standards and customer satisfaction, backed by a strong foundation in ISO 9001 and exceptional customer service skills. Achieved significant improvements in compliance and Quality training, underscoring a commitment to excellence and regulatory adherence.

Overview

11
11
years of professional experience
1
1
Certification

Work History

Assistant Manager – Compliance QA

M/s Abbott Healthcare Pvt Ltd
05.2023 - Current
  • Ensuring 100% compliance to Statutory, regulatory requirements for site by coordination with authorities.
  • Leading Audit readiness program and ensure 24X7 audit readiness for planned and unplanned regulatory
    inspection.
  • Responsible for internal audit program and ensure full compliance to all policies and standards.
  • Coordinates/manages all phases of the audit, including planning, notification, and discovery and reporting
  • Ensuring quality audits are conducted at sufficient frequency to assure compliance to and effectiveness of quality
    policies.
  • Using six sigma and Lean concepts, other quality processes to improve manufacturability, process variation and
    customer quality.
  • Maintaining the Quality system documentation, document change controls, Internal and external audits,
    Management review, CAPA management, Product surveillance management ensuring 100% compliance to
    Regulatory and global policy requirements.
  • Ensuring a level of governance is in place with respect to all stakeholders associated with site to deliver
    compliance.
  • Performing gap analysis between corporate policies, site policies, SOPs and regulatory requirements applicable
    at site and develop action plans to close the gap to mitigate risk.
  • Handling the Products registration for export requirements to different countries in compliance to respective
    country regulation.
  • Coordinating with cross functions teams including Business development, production, Supply chain,
    Procurement, Regulatory, Legal to ensure timely product delivery.
  • Ensuring a level of 'governance' is in place with respect to all vendors associated with site to deliver compliance.
  • Ensuring batch release activity as per regulatory and global policy requirement.

Site Document Controller

Abbott Healthcare Pvt Ltd
10.2021 - 05.2023
  • Controlling organization and project documentations.
  • Following and improving document control procedures.
  • Ensuring compliance of site SOPs / procedures with global policies and standards.
  • Sorting, Storing and Retrieving electronic and hard copy documents.
  • Producing document progress reports for management.
  • Conducting regular reviews and document audits
  • Using M-Files DMS and Teamcenter software to organize and distribute documents within a company.
  • Helping in the planning stages of a specific project
  • Ensure documents are shared at key times to facilitate timely project completion.
  • Internal Audit execution.
  • Preparation, Review and Approval of SOPs as per Abbott Guidelines.
  • Risk assessment of process through HACCP and developing plan for risk mitigation.
  • Continuous monitoring and updating of documents to reduce GDP/GMP related errors to ensure compliance with data integrity requirements.

QA Executive

Abbott Healthcare Pvt Ltd
11.2018 - 10.2021
  • Site Internal Audit coordinator, responsible for preparing Internal audit plan and scheduling annual Internal Audits and Raw Material Warehouse.
  • Preparing and managing the proof books for Internal and External audits.
  • Lead team for backup room and supporting audit execution.
  • Review and process the documents (Manufacturing direction, Batch records, SOP, Work instruction, Product Packing Specification, Commodity acceptance program etc.) in Abbott Document Software QDMS, M-Files & Teamcenter

QA Officer - Raw Material & Packing Material

Abbott Healthcare Pvt Ltd
08.2015 - 10.2018
  • Sampled as per AQL, Abbott & regulatory requirements for cross functional teams.
  • Tested of Raw Material and Packing Material.
  • Raw material & Finish product report reviewed.
  • Released Raw and Packing Material in SAP.
  • 6S & GMP maintenance in area, audit ready area all the time
  • Change management w.r.t IQA lab operation.
  • Part of Risk Management, RCA, FMEA
  • Handled of Event, OOS and OOT
  • Performed the impact assessment for process related changes & new supplier introduction etc.
  • Execution of qualification and requalification.

Marketing Executive

M/s Vilas Transcore Pvt Ltd
11.2013 - 08.2015
  • Make New Customers & Marketing products
  • Participate Fairs, Expo and make customer data base form making new customers Ensuring Customer get timely delivery of orders Take Orders and give planning to production team for execute orders
  • Ensuring comply get timely payments from customers.

Executive Client acquisition

M/s Indiamart Intermesh Ltd
05.2013 - 11.2013
  • Make New Customers Marketing Service Call and setup meetings on daily basis Visit customers office and give awareness of services

Education

MBA (Marketing) -

G.T.U.
07.2013

B.E.(Food Processing Technology) -

A.D. Patel Institute of Technology, New V.V. Nagar (S.P. University) -Anand
07.2011

Diploma in Dairy Technology -

IGNOU, New Delhi
07.2011

High School - Secondary High Schooling

Lal Bahadur Shastri Vidhyalaya
Vadodara, India
05.2007

Skills

  • Food Quality Assurance
  • HACCP
  • FSSC 22000
  • FSSAI
  • BIS
  • Legal Metrology
  • Internal Audit
  • Supplier Qualification
  • Documentation

Certification

  • Food Safety Supervisor certification – FOSTAC
  • Certified FSSC 22000 Internal Auditor
  • Yellow Belt Six sigma champion
  • Certified CII Assessor for Quality & Food Safety Audits

Software Skills

  • M-Files DMS and VMS
  • Abtraq
  • SAP
  • Maximo
  • TeamCenter
  • Veeva

Timeline

Assistant Manager – Compliance QA

M/s Abbott Healthcare Pvt Ltd
05.2023 - Current

Site Document Controller

Abbott Healthcare Pvt Ltd
10.2021 - 05.2023

QA Executive

Abbott Healthcare Pvt Ltd
11.2018 - 10.2021

QA Officer - Raw Material & Packing Material

Abbott Healthcare Pvt Ltd
08.2015 - 10.2018

Marketing Executive

M/s Vilas Transcore Pvt Ltd
11.2013 - 08.2015

Executive Client acquisition

M/s Indiamart Intermesh Ltd
05.2013 - 11.2013

MBA (Marketing) -

G.T.U.

B.E.(Food Processing Technology) -

A.D. Patel Institute of Technology, New V.V. Nagar (S.P. University) -Anand

Diploma in Dairy Technology -

IGNOU, New Delhi

High School - Secondary High Schooling

Lal Bahadur Shastri Vidhyalaya

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PAVAN SHAH