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ESO QA Specialist

5 years

0 Lacs

Ankleshwar Gujarat India

Posted:1 month ago| Platform: Linkedin logo

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Skills Required

management portfolio assessment evaluation stability compliance maintenance support mdr regulations auditing audit audits monitoring reporting communication negotiation collaborative

Work Mode

On-site

Job Type

Full Time

Job Description

MISSION STATEMENT

To ensure the quality lifecycle management for dedicated, subcontracted, product portfolio. Qualified auditor.

Main Accountabilities And Duties

Operational skillsOperational quality management of a dedicated product portfolio which includes:
  • Quality management of deviation and complaint records and their related CAPAs
  • Assessment and management of change controls
  • Edition of QA Agreements with Zentiva third parties and subcontractors
  • Collection and evaluation of PQRs and stability data
  • Compliance evaluation of Third Parties and products
  • Maintenance of product database
  • Collection and review of CoA/CoC
  • QA support of product launches and transfers
  • GMP, GDP, MDR, HACCP, Food Supplements and Cosmetics regulations and legislations
Auditing
  • Prepare audit and audit plans
  • Conduct and participate to external audits
  • Evaluation of audit reports
  • Participate to internal audits and inspections
KPI monitoring and reportingOther tasks may be performed under the direction of the Manager within the agreed type and scope of work.

Required Qualifications, Experience & Skills

  • University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
  • Minimum of 5 years in a similar role or equivalent experiences in a GMP related environment
  • Thorough knowledge of GMP requirements as well as knowledge of ICH and pharmaceutical regulatory requirements
  • Management of subcontractors is an advantage
  • Proven track record of project management skills
  • Strong communication skills and negotiation strength
  • Proactive attitude
  • Problem solving skills
  • Hands-on attitude, flexible and open minded
  • Collaborative and team-spirited
  • Knowledge of IT tools
  • Language - English: Advanced level

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