Onsite Specialist GMP Inspections & Audits

Posted 17 hours ago

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About the role

  • GMP Specialist coordinating document-based inspections for international regulatory authorities. Supporting clients with documentation during inspections at their sites, primarily for Vetter Pharma.

Responsibilities

  • You independently coordinate document-based GMP inspections conducted by international regulatory authorities (e.g., Korea, Japan, USA) and manage all related document requests.
  • You act as the central contact for records requests, assessments and regulatory inquiries and develop proposed solutions in response to deficiency letters.
  • You support our clients with regulatory document requests during inspections at their sites.
  • You handle GMP questionnaires from external customers and continuously develop our internal self-assessment questionnaires.
  • You prepare qualified statements regarding audit systems and inspections and review Quality Agreements with respect to audit and inspection requirements.
  • You coordinate document requests during international on-site inspections or audits at Vetter and support the backup office during ongoing inspections.

Requirements

  • Completed degree in a scientific or technical discipline, or an equivalent qualification, with several years of professional experience.
  • Initial professional experience—ideally in the context of inspections and audits.
  • Experience in a GMP environment or another regulated sector.
  • Very good command of English.
  • Enjoyment of communication with internal and external stakeholders.
  • Good German skills (minimum C1 level) to document your work effectively and communicate well with the team.

Benefits

  • Independent, interdisciplinary working in a family-owned company with modern workplaces and innovative technologies.
  • Strong team and career opportunities — exchange of ideas and many training and development opportunities at one of the leading pharmaceutical service providers.
  • Attractive compensation — our remuneration package includes a fixed salary, variable pay, tailored benefits and a company performance bonus awarded to each employee when company targets are met. This also includes shift and overtime premiums as well as holiday pay.
  • Fair work–life balance — at least 30 days of vacation, flexible working hours, measures to support work–family balance and the option for partial remote work.
  • Vetter benefits program — an ideal combination of company pension schemes and a time-value account (e.g., company supplemental health insurance).
  • Company health management with fitness and sports offers (EGYM Wellpass).
  • Personal perks (Deutschland-Ticket, Vetter holiday homes, JobRad bike leasing, employee discounts, and more).

Job title

Specialist GMP Inspections & Audits

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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