For our client, a leading company in the pharmaceutical sector, we are seeking a Technical Development Specialist.
The successful candidate will support and own the Corrective and Preventive Actions (CAPAs) and actions arising from deviations and GMP inspections. The role involves working closely with QC-Capability Leads (QC-CLs) to maintain and improve compliance within our IMP QC operations.
...
technical development specialist (m/f/d).
- basel, basel-stadt
- posted 1 day ago
- closes 31 march 2025
job details
summary
- basel, basel-stadt
- contract
- job categorybiotechnology & pharmaceutical
job details
The perfect candidate has a MSc in Pharmaceutics, Analytical Chemistry, or a related field and minimum of 2 years of experience working in a GMP environment. It is really important that the candidate also has strong knowledge of GMP and the ability to work effectively in a fast-paced, team-oriented environment.
General Information:
- Start date: ASAP
- Latest Start Date: 01.04.2025
- Planned duration: 6 months
- Extension: possible
- Workplace: Basel
- Workload: 80-100%
- Home Office: possible 1-2 days per week
- Working hours: Standard
Tasks & Responsibilities:
CAPA and Deviation Management:
- 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.
GMP Support:
- 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.
- 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.
Monitoring and Reporting:
- 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 (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 is an advantage)
For our client, a leading company in the pharmaceutical sector, we are seeking a Technical Development Specialist.
The successful candidate will support and own the Corrective and Preventive Actions (CAPAs) and actions arising from deviations and GMP inspections. The role involves working closely with QC-Capability Leads (QC-CLs) to maintain and improve compliance within our IMP QC operations.
The perfect candidate has a MSc in Pharmaceutics, Analytical Chemistry, or a related field and minimum of 2 years of experience working in a GMP environment. It is really important that the candidate also has strong knowledge of GMP and the ability to work effectively in a fast-paced, team-oriented environment.
General Information:
- Start date: ASAP
- Latest Start Date: 01.04.2025
- Planned duration: 6 months
- Extension: possible
- Workplace: Basel
- Workload: 80-100%
- Home Office: possible 1-2 days per week
- Working hours: Standard
Tasks & Responsibilities:
...
CAPA and Deviation Management:
Must Haves:
show more- 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.
GMP Support:
- 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.
- 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.
Monitoring and Reporting:
- 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 (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 is an advantage)
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