Einführung

Operational Excellence and Quality Assurance Lead in Manufacturing

Stellenbeschreibung

• During the initiation and setup of new production lines, overseeing the preparation in manufacturing, encompassing materials handling, ensuring cleanroom standards, organizing training sessions, and ensuring regulatory compliance
• Engaging in the transition of new technological products
• Aiding in CVQ, PQ, and the enactment of Process Validation
• Overseeing daily manufacturing assistance, covering regulatory compliance, tracking KPIs, workflow scheduling, materials oversight, managing changes, conducting inquiries, handling CAPA, and related tasks
• Driving and refining optimal manufacturing practices to ensure efficient and stable operations
• Guaranteeing strategic plans for role succession
• Engaging in setting consistent process metrics during regular production phases
• Forming and coordinating with multifunctional teams, collaborating with auxiliary sectors like Quality Assurance, Quality Control, Production, Engineering, Validation, and other pertinent departments
• Certifying the adoption and strict adherence to the latest GMP guidelines, and quality standards, processes, and directives within their purview
• Committing to persistent quality enhancement drives and reporting and monitoring discrepancies
• Establishing and complying with EHSS regulatory standards, guidelines, policies, procedures, and directives in their designated area
• Participating in EHSS strategies as well as concerns and ensuring prompt reporting and tracking of near-miss incidents
• Assuming personal responsibility for their attendance, output, and proficiency in achieving set goals

Erwartetes Profil

• Degree in Chemistry, Biochemistry, Biology, or Food Science (Bachelor's/Master's level)
• Proficiency in English; proficiency in German is beneficial
• Over 7 years of notable experience in pharmaceutical operations within a GMP-compliant setting
• Background in biotechnological processes, maintaining sterile conditions, handling single-use equipment, CIP/SIP processes, and budget management is necessary
• Prior experience with single-use technology is highly valued
• Familiarity with matrix management structures
• Openness to travel, approximately 15% of the time
• Anticipation of on-call responsibilities roughly one weekend each month