Pharmaceutical Quality Compliance Specialist
Vor 3 Tagen
Randstad is seeking a highly skilled Pharmaceutical Quality Compliance Specialist to support and own Corrective and Preventive Actions (CAPAs) and actions arising from deviations and GMP inspections.
Job OverviewThe successful candidate will work closely with QC-Capability Leads (QC-CLs) to maintain and improve compliance within our IMP QC operations. The ideal candidate has a MSc in Pharmaceutics, Analytical Chemistry, or a related field and minimum of 2 years of experience working in a GMP environment.
Main Responsibilities:- 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.
- Maintain inspection readiness by continuously improving compliance processes and documentation.
- 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.
- 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.
- Monitor the effectiveness of implemented CAPAs and GMP actions.
To be considered for this role, you must have:
- 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
This role offers a unique opportunity to make a significant impact on the quality of pharmaceutical products and contribute to the success of a leading company in the industry.
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