* Providing direct quality support (e.g. compliance, regulatory assessment, and validation) to the business unit, with a particular focus on maintaining the qualified status of equipment and systems during routine operation (autoclaves, fridges, freezers, cleanrooms, sterilization in place among others).
* Writing and implementing qualification documents and procedures required for compliance with pharmaceutical regulations.
* Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales.
* Evaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports; performs gap analysis to resolve efficiencies and take appropriate actions.
* Defines, in collaboration with other partners (Quality Assurance, System Owner…) the requalification strategy of GMP systems and implements it, including maintaining the quality system and complete practical activities.
* Coordinates execution of activities by external contractors.
* Performs requalification and revalidation Work Orders, including routine and non-routine operations, and documents in forms and OMX following Good Documentation Practices
* Participates in the culture of continuous improvement and development of technologies.
* Identifies training needs and develop training programs.
* Works in a safe and responsible manner in order to build an injury-free and incident-free workplace.
How you will get here
* A technical degree in a related field is required such as mechanical engineering, instrumentation, pharmaceutical science
* Four years in the pharmaceutical industry or a regulated industry is preferred.
Equivalent combinations of education, training, and meaningful work experience may be considered.
* Experience working in validation activities of steam sterilization processes and cleanroom qualification.
* Proficient in the use of computerized office applications (e.g. Word, Excel, Outlook) and systems/business applications, project management and confirmed scientific writing skills.
* Knowledge of cGMPs and FDA/industry expectations, especially quality systems such as deviations, CAPAs, and change control.
* Fluency in English is required, German skills are preferred.
* Outstanding attention to detail and organizational skills. Self-starter, mature, independent and diligent. Ability to work in a fast-paced environment under pressure, able to multi-task and is customer-focused Effective time management and prioritization skills.
* Requires discretion and independent judgment. Highly effective verbal and written communication skills.
* This position might be requested to participate in on-duty service (Pikettdienst) or work on shifts (nights/weekends)
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