Jobdescription For our client, an international pharma company in Basel, we are looking for a Technical QA Manager to support the end to end cGMP activities, in maintaining the Right to Operate at the Swiss Technical R&D sites and in ensuring quality and compliance of IMP products according to Health Authority requirements and Company Standards for IMP products. The perfect candidate is someone with at least 5 years of experience in QA, with a first experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics. General Information:
Start date: ASAP
Planned duration: 1 year
Extension: very likely
Workplace: Basel
Workload: 100%
Home Office: upon discussion
Working hours: Standard
Tasks & Responsibilities:
QA supervision of qualification- and validation-activities for GMP-relevant equipment (including CSV), Analytics, infrastructure, critical utilities (WFI, PW, Gas) and processes within TR&D in Basel
Support of implementation of DI requirements
Review and approval of GMP relevant Documents like Plans, Reports, SOPs, Change Control, Discrepancy Management, CAPA (corrective action and preventive action), Risk Analysis
Assist management in regulatory inspections and performing internal as well as partner audits Ensure adherence to cGMP requirements and Roche policies and standards in technical development functions
Apply advanced theory, quality principles, expert judgment and cross functional expertise to address complex problems independently
Provide technical and quality assurance input to review and approval of manufacturing and Quality related documents as appropriate, Serve as a Subject Matter Expert (SME) in support of departmental functions and build partnerships and collaborate with stakeholders in other areas of the business to ensure success of the quality.
Leading of complex risk assessments Leading resolutions of quality issues and establish work priorities to meet targets and timelines
Creation and periodic review of quality agreements (QAGs) with contract organizations including quality agreements between sites.
Cost conscious working and optimization of processes. Ensure the efficient use of the available resources (staff, equipment, machinery, working spaces, materials).
Assistance is required in the introduction and training of new employees.
Must Haves:
Degree in Engineering, Chemistry, Life Science, Pharmacy or equivalent
Min. 5 years of Quality Management related experience in the Pharmaceutical industry
Experience in Qualification/Validation and CSV of Small Molecules, Analytics and/or Biologics
Sound understanding on current DI (Data Integrity) requirements
Experience with MES (Manufacturing Execution System)
Profound knowledge of global quality and GMP requirements and a detailed understanding of current industrial trends in IMP
Proven ability to work towards results, excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
High expertise and experience in building and maintaining constructive and effective relationships with internal and external partners and stakeholders
Strong team-player with a high level of self-motivation and being able to inspire others
Ability to effectively influence others across all levels of the organization
Strong collaboration across cultures, countries, technical competencies, and organizational levels
Successful performance in health authority inspections and internal GMP audits
Fluent German and English (spoken/written) is a must for this position