
Quality Control Lead
Vor 4 Tagen
Company Overview
Roche is a leading pharmaceutical company with a strong presence in Basel, Switzerland. We have over 10,700 employees from more than 100 countries working together at our Basel/Kaiseraugst site.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Job Summary
We are seeking a highly motivated and experienced Quality Control Project Lead (QC-PL) to oversee and coordinate GMP analytics in Synthetic Molecules Technical Development. The QC-PL will be responsible for managing both API (Active Pharmaceutical Ingredient) and drug product release analytics.
Key Responsibilities
- Lead and oversee QC analytics to ensure compliance with GMP regulations, timelines, and quality standards.
- Ensure analytical testing is conducted according to regulatory guidelines, and data integrity is maintained.
- Review analytical data for precision, accuracy, and completeness.
- Ensure all analytics adhere to internal SOPs, GMPs, and regulatory requirements.
- Address and resolve issues related to QC analytics, including troubleshooting analytical methods and deviations.
Requirements
- Education: Bachelor's or Master's degree in Chemistry, Pharmaceutics, or a related field.
- Experience: Minimum of 2-3 years of experience in a GMP-regulated environment, with a focus on quality control (QC).
- Technical Skills: Strong knowledge of synthetic molecules testing methodologies, HPLC, GC, and other analytical techniques.
- Regulatory Knowledge: In-depth understanding of ICH guidelines, FDA, EMA, and other global regulatory requirements related to QC analytics.
- Project Management: Demonstrated ability to manage multiple projects simultaneously with a high degree of organization and efficiency.
Benefits
- Development and training opportunities.
- Flexible working options.
- 18 weeks of maternity leave and 10 weeks of gender-independent partnership leave.
- Multiple services on site, including child-care facilities, medical services, restaurants, and cafeterias.
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