Senior QA Specialist ESO

2 days ago

Ankleshwar, Gujarat, India Zentiva Full time US$ 90,000 - US$ 1,20,000 per year

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

Main Accountabilities And Duties

  • Operational skills

Operational 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 reporting
  • Other tasks may be performed under the direction of the Manager within the agreed type and scope of work.

Other Responsibilities
QUALITY

  • Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.

HSE

  • Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

  • All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations

COMPLIANCE

  • The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with the Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

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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