Senior • basel
Management and maintenance of quality assurance activities by supporting operational departments in accordance with agreed timelines as well as global and local standards to ensure the GMP complian...Mehr anzeigen
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Main Responsibilities:
·Management and maintenance of quality assurance activities by supporting operational departments in accordance with agreed timelines as well as global and local standards to ensure the GMP compliance within sterile manufacturing.
·Act as Quality single point of contact for the activities assigned
·Author, review and approve deliverables included but not limited to, such a SOPs, gap assessments, risk assessment, cleaning documents, WI)
·Coordinate, review and approve quality records included but not limited to, such as deviations, CAPAs, change controls, qualification and validation documentary) related to the manufacturing processes in Trackwise and KNEAT.
·Participate and provide support to Growth Projects 41X operational departments in alignment with cGMP
·Serve as QA oversight to ensure GMP compliance within manufacturing activities.
·Support SMEs during investigation, included but not limited, such as root cause analysis, impact assessment, action plan implementation.
·Participate in quality systems improvements projects and lead lean improvement projects to ensure efficiency in alignment with global and local standards
·Monitor local and global meetings as well as project progress to ensure efficient and effective communication on project status
·Liaise with external partners/customers to set up a release strategy for deliverables in alignment with corporate standards as well as global and local standards
·Deliver expertise in all matters concerning cGMP compliance as required
·Define, manage and report Quality Key Performance Indicators (KPI), as needed.
·Perform other agreed activities as assigned by the line manager.
·Execute, improve and maintain the Quality Oversight concept within DPS manufacturing.
·Provide QA support to Drug Product network
Qualifications and Experience:
·Relevant working/residency permit or Swiss/EU-Citizenship required
·University or academic degree (Master or Ph.D.) in Chemistry, Biology, Pharmacy or equivalent
·5-10 years of experience in Quality Assurance or Quality Control in a manufacturing environment within Pharmaceutical Industry
·Superior problem solving, decision making and planning skills
·Sets clear priorities for task for him/herself and the team
·Customer oriented and collaboration with Process Unit team
·Sound knowledge of cGMP and regulatory compliance of all relevant operations in the Process Unit
·Excellent English skills (spoken and written), German skills an advantage
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