Specialist – Engineering & CSV Compliance
Join our newly formed team within the Quality division at Alvotech, a leading biosimilar pharmaceutical company. As a Specialist in Engineering & CSV Compliance, you will collaborate with various departments to oversee qualification and validation activities for facilities, utilities, and equipment. You will serve as a Quality representative and subject matter expert, ensuring compliance with EU and US legislation for parenteral manufacturing. Your role will involve supporting QA oversight, reviewing and approving qualification documents, change controls, deviations, and CAPAs, and contributing to investigations and corrective actions. We seek a candidate with a bachelor's degree in a relevant area, at least 3 years of experience in the pharmaceutical or medical device industry, and a strong understanding of GAMP 5 guidelines.
- Accountable for completing own tasks or assignments
- Receives assignments from a leader or senior colleague
- Performs mostly routine tasks within procedures and processes but occasionally non-routine tasks
- Challenges and decisions are discussed, made and solved in cooperation with supervisor or other employees
- Can make adjustments or changes to procedures, processes and (occasionally) projects.
- Advanced knowledge within field of expertise such as methods, techniques and equipment as well as relevant procedural/process knowledge (SME)
- Main scope is local or internal that can require immediate or urgent expert attention
- A bachelor’s degree within relevant area, or other relevant business experience
- Ongoing relevant courses and training activities.
- Minimum 3 years of experience within the pharmaceutical or medical device industry
- Minimum 2 years Quality Assurance experience
- Experience working with regulatory requirements in GxP required
- Good understanding of GAMP 5 guide required.
- Knowledge of and experience with validation and qualification specifically within facility, utility, and equipment
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