Corporate Quality Projects | Sun Pharma | Vadodara

Manufacturing, QA/QC/QMS/IPQA/CQA
Gujarat
March 20, 2023
Full Time
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Job Overview

  • Date Posted
    March 20, 2023
  • Location (State / UT)
    Gujarat
  • Expiration date
    --
  • Experience
    10 Years, 12 Years
  • Gender
    Any
  • Desired Qualification
    Master’s Degree, Bachelor Degree

Job Description

Roles and Responsibilities

  • To have the knowledge & complete understanding of Quality Control functionality.
  • To have hands-on experience in team handling and project management.
  • To have an understanding of the dynamics of computerized systems wrt regulatory standards and functional requirements (21 CFR part 11, 210 & 211, GAMP, Eudralex, ICH Quality guidelines, etc).
  • To identify the roadblocks and ensure the smooth execution of assigned projects.
  • To support functional and project teams for timely execution and completion of assigned activities.
  • To perform the assigned activities regarding functional designing, Masterdata preparation, SOP preparation, qualification execution, and testing as per the project requirements.
  • To identify the actionable and accomplish the project milestone.
  • To prepare and review SOPs, and qualification scripts, and ensure execution of qualification.
  • To prepare, ensure and support database and design preparation as per compliance requirements and functional needs.
  • To ensure techno-functional training/support for each site, whenever required.
  • To support site SMEs for the Stabilization of projects.
  • To conceptualize and frame a consolidated approach for newly identified techniques regarding quality system automation.
  • To ensure customer support for technical discussion on project finalization.
  • To execute and support automation projects or any other project initiated for simplification, harmonization, and productivity enhancement.
  • To work in collaboration with IT, API, Operations, vendor, Site Quality, and different teams for identification of the right solution /tool/Vendor, to resolve the “Specific problem statement” and have the correct solution for the organization.
  • To ensure the successful handover of projects to their respective functional team.
  • Support sites during regulatory audits, and internal/external audit observations.

Qualification:  B.Pharma, M.Pharma

Experience: 10-12 years

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