Sr Specialist QC Services

d organizes required training related to different qualification and validation activities

• Coordinates equipment/system qualification and validation activities within the Quality Control Department

• Writes and supports the writing of various documents regarding qualification and validation of equipment and automated systems (e.g. equipment process documents, URS, Data Integrity Assessment, IQ, OQ, PQ)

• Acts as equipment business administrator

• Coordinates & manages the timely and effective completion of equipment related investigations, change controls and CAPA's related to equipment activities

• Partners with internal and external stakeholders for implementing new technical analytical capabilities, systems, equipment and new equipment related processes within QC Operations to maintain and expand the site's product capability.

• Manages and supports development, justification, and implementation of QC capital expenditures, ensuring all projects adhere to appliable compliance regulations and are within the given budget

• Act as business equipment subject matter expert in audits

• Help to build a strong team to expand, strengthen and maintain the current knowledge base and expertise within QC to reflect changing business needs

Qualifications

• University degree in natural sciences, applied sciences or equivalent working professional experience

• Know-how of commissioning and qualification requirements according to c(GMP) regulations preferably in a laboratory environment

• Proven experience in computer system validation in a GMP environment and good knowledge of related regulatory environments in the life science industry (GAMP 5, 21 part 11,...)

• Min 5-8 years relevant industry experience.

• Must be well organized, a self-starter, results oriented individual with the ability to multitask in a fast paced team environment with attention to detail and good documentation practice

• Strong strategic and conceptual skills, analytical thinking and problem-solving ability

• Strong project management skills

• Proactive attitude, Team player, team builder

• Good verbal and written skills in English, German benefiitial

We are offering you a multifaceted challenge in a dynamic, international environment with attractive terms. Have we piqued your interest? Please send us your online application (CV, Working References etc.)

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.