Maheen Rafat

Experience

• 

  Bayer Pakistan (Pvt) Ltd.

  Jun 2010 - Jul 2010

  Interne

  One week training in Solid and Semi-Solid Manufacturing and Packaging of the production department.One week training in Quality Control department and demonstration of principles of HPLC and FTIR.Two days training in Warehouse and cover areas of cold storage.Two days training in Engineering Department and cover detail orientation of HVAC System.Prepared project presentations and reports to assist senior staff.

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  BSN medical

  Sept 2013 - Jul 2016

  QA & RA Officer

  Demonstrated leadership skills in managing projects from concept to completion.Passionate about learning and committed to continual improvement.Organized and detail-oriented with a strong work ethic.Identified issues, analyzed information and provided solutions to problems.Skilled at working independently and collaboratively in a team environment.Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.Cultivated interpersonal skills by building positive relationships with others.Managed time efficiently in order to complete all tasks within deadlines.Paid attention to detail while completing assignments.Developed strong communication and organizational skills through working on group projects.Facilitate the Regulatory Bodies to carryout the External Inspections.Maintain Non-Conformity Records of Internal Audit.Facilitates the process of cGMP & ISO Certifications.Carryout the Internal Audits of different departments biannually according to ISO 9001:14001 standards and Company Procedures. Show less

• 

  Getz Pharma

  Aug 2016 - now

  Manages work activities in markets of Central America, CIS (Common wealth Independent States) Region, East Africa Countries, ASEAN (Association of South East Asian Nations) Region and EAEU (Euro Asian Economic Union) Region which consist of regulatory specialists, advisors and analysts.Performed and documented quality control checks to maintain compliance with company initiatives.Prepared and maintained document inventory for core dossier preparation.Represented company during communications with global regulatory agencies.Prioritized project-related tasks to efficiently complete essential tasks.Assisted with regulatory product compliance initiatives such as implementation of requirements of data matrix in CIS market.Directed documentation efforts to comply with international regulations and standards.Consulted with regulatory representatives to manage filings, applica Show less

  • Manager Regulatory Management

    Jan 2023 - now

  • Associate Manager Regulatory Management

    Jan 2022 - May 2023

  • Assistant Manager Regulatory Management (Grade-02)

    Jan 2021 - Dec 2021

  • Assistant Manager Regulatory Management (Grade-01)

    Jan 2019 - Dec 2020

  • Sr. Executive Regulatory Management

    Jan 2018 - Dec 2018

  • Executive Regulatory Management

    Aug 2016 - Dec 2017