Global GMP Auditor

2 weeks ago

Bucharest, Bucureşti, Romania Zentiva Full time €40,000 - €80,000 per year

Be a part of the winning culture
At Zentiva, we are a team of 4.700 unique talents bonded together by our common mission. We believe our diversity is a source of great energy and strength, and we create a work culture and ethics where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love.

Currently, we are looking to fill the role of a GMP Auditor. The main purpose of this person will be to act as an independent Quality Systems Auditor, provide an independent assessment of Quality Management Systems of audited Zentiva third parties (CMOs, material and service providers).

Main Responsibilities

  • To act as qualified GxP auditor based on the Zentiva internal and third party audit plan.

  • To negotiate the audit date with auditee

  • To prepare data for the audit
  • To manage the audit trip
  • To carry out the audit
  • To write the audit report and ask for CAPA proposal
  • To check and confirm the CAPA proposal
  • To follow up CAPA if needed

  • To manage all audit documents in Quality Forward and other systems

  • To review the audit reports done by the external companies and manage them in Quality Forward .

  • To participate in trainings/self-trainings.
  • To help set up the Zentiva auditor training process and participate as the lector.
  • To prepare and justify regular reporting in respective area.
  • The employee will perform other tasks under the direction of the Manager within the agreed type of work.

Requirements

  • University education (pharmacy, chemistry, pharma technology, biology etc.).
  • English language in writing and speaking, other language is the advantage (Czech is not mandatory).
  • Microsoft Office profficiency – Excel, Word, Outlook.
  • Experience in pharma industry or quality lag is a must.
  • Experience as the GMP / GDP auditor at least two years.
  • Experience with Quality Forward is an advantage.
  • Ability to learn / quick adaptability / analytical / organized / communicative.
  • To follow requirements of solid line manager and job description.
  • To follow tasks and timelines, set for particular activities and projects.
  • To work independently, to be proactive.
  • Ability to travel worldwide esp. Europe and Asia (up to 70% of working time).
  • Certification as GMP auditor (ECA, IRCA …) is an advantage.
  • Driving license B – active driver.

What Is In It For You

  • An opportunity to work for a successful international pharmaceutical company.
  • An opportunity to learn newest approaches in managing creative and highly adaptive business organizations.
  • Pleasant and dynamic working environment.
  • Continuous personal development.
  • An attractive compensation & benefits package.
  • Above standard social and benefit program.

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