Experienced Analyst Quality Systems - Temporary 12 months (ID: 2506238798W), Location: Schaffhausen

This position may represent Quality on Risk Management, NC/CAPA and Change Control, APR/PQR (Annual Product Review/Product Quality Review) by being responsible for on time completion of activities, guiding, setting, and standardization of quality/compliance requirements, development of SOPs and providing practical solutions in collaboration with the business process owners. This individual will comply with applicable regulations and meet the needs of the business and supply chain. This individual brings experience in Process Excellence, Data Analytics and Transformation Tools as well as Digital Innovation.

Responsibilities:

• Process Excellence: bring forward and implement innovative process improvements to drive compliance, standardization, simplification and/or efficiency of the below Quality System Processes.
• Embed Process Excellence through Data Analytics and Data Transformation Tools, Digital Innovation and Automation using Microsoft 360 tools (PowerApps, PowerBI, PowerAutomate) as well as Tableau and GenAI.
• Build and roll-out visualizations with the above tools.
• Support several Business Process Owner (BPO) in the daily business regarding Quality Risk Management (QRM), Quality System Management Review (QSMR), Annual Product Review (APR) / Product Quality Review (PQR), NC/CAPA and Change Control Process while ensuring compliance with current and proposed J&J and regulatory requirements.
• Work in close collaboration with BPOs. Provide overview or detailed proactive communications to BPOs.
• Collaborate within local and global teams.
• Deliver metrics for the above processes.
• Support BPO in regulatory agency inspections and customer audits.
• Ensure timeliness of results through independent, proactive intervention and pro-active communication.
• Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective.
• Review and approve compliance records, procedures and other documents, as required by procedure.
• Identifies, supports assessment and documentation of issues that might pose compliance risks, supporting investigation and solutions, actions, and recommendations.

• A minimum of a Bachelor’s Degree is required, preferably in Engineering, Chemistry, Biology, Biological Sciences or Food Sciences field.
• A minimum of five (5) years of GMP experience in either Pharmaceutical, Medical Device, OTC Drug, Cosmetic Production is required.
• Alternatively, a minimum of a laboratory technician EFZ, preferably with HF certification and a minimum of seven (7) years of experience in and outside of Quality Control with increasing responsibility
• Demonstrated skills in Process Excellence preferred.
• Strong experience with Microsoft 360 tools (PowerApps, PowerBI, PowerAutomate) as well as Tableau and GenAI. Coding experience with Python and SQL for data transformation preferred.
• Proven ability to lead and influence others with very good communication and presentation skills.
• Experience and demonstrated skills in navigating in a matrix environment, handling complexity, collaborating across boundaries, and influencing without authority required.
• Ability to work in a fast-paced environment with multiple, concurrent priorities many needing immediate resolution.
• Strong communication (verbal & written) and interpersonal skills, self-awareness and flexibility required.