Technical Development Specialist

Proclinical 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.

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