Highly Motivated Technical Development Specialist Needed for GMP Compliance Role

vor 10 Stunden

Basel, Basel-Stadt, Schweiz Work Selection AG Vollzeit

Work Selection AG is seeking a skilled and experienced Technical Development Specialist to join their team on a temporary contract basis. The ideal candidate will possess a strong background in GMP regulations, analytical method validation, and troubleshooting.

About the Job

We are looking for an individual who can lead and manage CAPAs and actions from deviations, ensuring timely and effective implementation. The successful candidate will conduct thorough investigations of deviations to determine root causes and develop appropriate CAPAs.

Key Responsibilities:

  • Lead and manage CAPAs and actions from deviations
  • 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

The ideal candidate will possess the following skills and qualifications:

  • MSc in Pharmaceutics, Analytical Chemistry, or a related field
  • 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

What We Offer:

  • A dynamic and challenging work environment
  • The opportunity to work with a talented team of professionals
  • A competitive compensation package

At Work Selection AG, we value diversity and welcome applications from candidates of all backgrounds. Please submit your application documents online today.

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