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À±½·ÊÓƵ is seeking a skilled Technical development specialist to focus on Corrective and Preventive Actions (CAPAs) and managing actions from deviations and GMP inspections. This role requires collaboration with QC-Capability Leads to enhance compliance within IMP QC operations. The ideal candidate is someone with a strong background in GMP environments and a proactive approach to quality assurance.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Lead and manage CAPAs and actions from deviations, ensuring timely and effective implementation.
• Conduct thorough investigations to determine root causes and develop appropriate CAPAs.
• Document all CAPA activities in compliance with GMP regulations and procedures.
• Maintain inspection readiness by improving compliance processes and documentation.
• Collaborate with QC-Capability Leads to align on CAPA implementation and compliance improvements.
• Provide expert guidance to QC-CLs on GMP issues and quality system enhancements.
• Facilitate communication and coordination between departments for consistent compliance practices.
• Identify areas for quality system improvements and lead initiatives to enhance compliance.
• Develop and update SOPs and other quality documentation as needed.
• Conduct training sessions to reinforce GMP compliance.
• Monitor the effectiveness of implemented CAPAs and GMP actions.
• Compile and present reports on CAPA status, trends, and improvement initiatives to senior management.
• Communicate compliance issues and action plans to relevant stakeholders.

Key Skills and Requirements:

• MSc in Pharmaceutics, Analytical Chemistry, or a related field; PhD is advantageous.
• Experience in a GMP environment with a focus on HPLC and GC analytics.
• Expertise in analytical method validation and troubleshooting.
• Strong knowledge of GMP regulations and guidelines.
• Excellent organizational, communication, and problem-solving skills.
• Ability to work effectively in a fast-paced, team-oriented environment.
• High attention to detail and commitment to quality and compliance.
• Experience with additional analytical techniques.
• Leadership or project management experience.
• Familiarity with electronic laboratory information management systems (LIMS, LES, SAP).
• Fluency in English; German is a plus.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

À±½·ÊÓƵ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓƵ is acting as an Employment Agency in relation to this vacancy.