Technical Development Specialist (m/f/d)

For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated Technical Development Specialist for a temporary contract of 6 months with the option to extend.

Tasks

• Lead and manage CAPAs and actions from deviations, ensuring timely and effective implementation.
• Conduct thorough investigations of deviations to determine root causes and develop appropriate CAPAs.
• Document all CAPA activities in compliance with GMP regulations and company procedures.
• Maintain inspection readiness by continuously improving compliance processes and documentation.
• Collaboration with QC-Capability Leads (QC-CLs):
• Work closely with QC-CLs to ensure alignment on CAPA implementation and compliance improvements.
• Provide expert guidance and support to QC-CLs in addressing GMP issues and enhancing quality systems.
• Facilitate regular communication and coordination between departments to ensure consistent compliance practices.
• Quality System Improvements:
• Identify areas for improvement within the quality systems and lead initiatives to enhance compliance.
• Develop and update SOPs (Standard Operating Procedures) and other quality documentation as needed.
• Conduct training sessions and workshops to reinforce GMP compliance across the organization.
• Monitor the effectiveness of implemented CAPAs and GMP actions.
• Compile and present regular reports on CAPA status, trends, and improvement initiatives to senior management.
• Ensure timely communication of compliance issues and action plans to relevant stakeholders

Must Haves

• MSc in Pharmaceutics, Analytical Chemistry, or a related field. A PhD is an advantage
• Minimum of 2 years of experience working in a GMP environment with a strong focus on HPLC and GC analytics
• Demonstrated 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 a commitment to maintaining the highest standards of quality and compliance
• Hands-on experience with additional analytical techniques
• Previous experience in a leadership or project management role
• Familiarity with electronic laboratory information management systems (LIMS, LES, SAP)
• English fluent, German would be a Plus

Are you interested? Do not hesitate and submit your complete application documents online today.
 

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Kontakt
Kristof Wildmann

Arbeitsort
Basel

Pensum
80 - 100%

Position
Mitarbeiter

Branche
IT