Local Quality Owner

ph3Local Quality Owner Late Stage Value Optimizer (f/m/d), 80-100% /h3 pLocation: Schaffhausen, Switzerland /p pCilag AG in Schaffhausen, Switzerland is part of the Johnson Johnson Innovative Medicine (JJ IM) Supply Chain organization and is currently recruiting for a role focused on QA oversight of a selected portfolio of established (Combination-) Products manufactured at the JJ IM Schaffhausen site. /p pWe manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and accelerating growth in parenterals, supported by an impressive pipeline of new and innovative products. /p h3Position summary /h3 pThe function holder is responsible for the QA oversight of a selected portfolio of established (Combination-) Products, which are manufactured at the JJ IM Schaffhausen site. /p h3Principal responsibilities /h3 ul liKey Contact for internal and external stakeholders (operations, planning, logistics, engineering, regulatory affairs etc.) within cross‑functional teams in terms of Quality and Compliance. /li liQC contributions including Decision making and problem solving and oversight of assigned, established manufacturing lines. /li liInvestigation lead for major non–conformances (deviations) including CAPA alignment with Operations counterparts. /li liIn‑time release of parenteral products (intermediate and finished products). /li liProactive risk mitigation. /li liReview and approval of non‑conformances (deviations) records and change requests. /li liReview and approval of GMP critical SAP master data (e.g. bill of material, manufacturing instructions etc.). /li liReview and approval of work instructions and standard operating procedures. /li liSupport of cross‑functional and global projects. /li liReview of Annual Product Reviews. /li /ul h3Qualifications /h3 ul liA minimum of a Bachelor’s degree, preferably in a technical/scientific field. A Master’s degree or advanced is desirable. /li liMinimum of 5 years of experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role. /li liStrong understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes. /li liIn‑depth knowledge in GMP standards, policies and procedures. /li liKnowledge about regulatory guidelines preferred. /li liAdvanced communication skills, verbal and written in both English and German. /li /ul pWe are looking for a dynamic and solution‑oriented individual eager to contribute to our team and drive success in a collaborative, international and fast‑paced environment. If you see yourself in this role, we encourage you to share your application materials with us without hesitation. /p pRequired Skills: Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, Human‑Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP) /p /p #J-18808-Ljbffr