How you will make an impact
- 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)