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).
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