QA Manager (m/f/d)

Duration: 13 months

Location: Basel

Workload: 100%

The perfect candidate has a degree in pharmacy, natural sciences, engineering or a corresponding professional training, combined with many years of professional experience in the GMP sector. 3-5 years of experience in pharmaceutical production, development or quality assurance, preferably in the field of aseptic manufacturing and/or packaging and/or the manufacture of solid dosage forms is required.

Responsibilities:

• Collaboration and support as QA in the respective technical transfer and launch teams (local and global teams).
• Collaboration in an optimization project of existing plants. This includes, among other things, the categorization of the URS requirements and the improvement of all systems in terms of data integrity
• QA responsibility for all qualification and validation (QV) aspects of the equipment, which take place as part of technical transfers and launches.
• Classification and approval of amendments and processing of deviations.
• Review and approval of GMP-related documents such as plans, reports, SOPs, deviation management, change management, CAPA (corrective and preventive actions), risk assessment.
• Local support in the implementation of global standards and requirements.
• Working closely with internal and external interfaces to achieve our ambitious goals for safety, turnaround time, quality, commitment and costs.

Requirements:

• Completed studies in the field of pharmacy, natural sciences, engineering
• Fluent German and English
• Min. 3-5 professional experience in pharmaceutical production, development or quality assurance, preferably in the field of aseptic manufacturing and/or packaging and/or the manufacture of solid dosage forms.
• Experience in qualification and a sound knowledge of data integrity requirements.
• High affinity for technical issues and GMP compliance around the topics of validation, plant and device qualification, computerized systems validation and data integrity.