Specialist GMP Inspections & Audits
Vetter Pharma
full-time
Posted on:
Location Type: Office
Location: Ravensburg • Germany
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About the role
- 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).
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP inspectionsdocument managementaudit systemsregulatory compliancequality agreementsself-assessment questionnairesdeficiency lettersregulatory inquiriesdocument requestsinspections
Soft Skills
communicationstakeholder engagementproblem-solvingcoordinationorganizational skillsattention to detailteam collaborationadaptabilityinterpersonal skillscustomer service