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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