Chemist Quality Assurance (m/w/d)

CARBOGEN AMCIS AG; Vionnaz; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Benefits dieser Stelle

A dynamic working environment withhigh

High-quality facilities

At least 5 weeks’ holiday

Childcare costs

Travel insurance

Private accident insurance

13th month salary

Profit-sharing bonus

Zusammenfassung

CARBOGEN AMCIS AG in Switzerland seeks a Quality Assurance professional to support the Sr. Manager QA in a GMP-regulated environment.

You will review batch documentation and analytical results, and decide final status for intermediates and finished products, ensuring GMP compliance. We require a degree in chemistry or related fields, with experience in QC/QA in chemical or pharmaceutical industry, and strong knowledge of GMP.

Qualifikationen

• Degree in Chemistry, Pharmacy, Analytical Chemistry, Food Chemistry or a comparable scientific qualification.
• Professional experience in Quality Control or Quality Assurance within the chemical or pharmaceutical industry.
• Strong knowledge of organic preparative and/or analytical chemistry.
• Solid understanding of GMP and ideally other quality systems such as ISO 9001 or GLP.
• Experience in batch record review and handling quality-related documentation.
• Proficient in MS Office; knowledge of LIMS, chromatography data systems and SAP/ERP is an advantage.
• Very good German and good English communication skills, both written and spoken.
• Independent, accurate and reliable working style with strong communication and teamwork skills.

Aufgaben

• Support the Sr. Manager QA in all quality related activities within a GMP-regulated environment.
• Review batch documentation and analytical results, and perform final status assignment or rejection of intermediate and finished products.
• Review, assess, and approve quality-related documents (e.g. manufacturing instructions, analytical procedures, validation and qualification documentation, and Certificates of Analysis (CoAs)).
• Ensure compliance with applicable GMP requirements and actively contribute to the continuous improvement of the Quality Management System (QMS).
• Review and manage deviations, change controls, CAPAs, and customer complaints in accordance with internal procedures and regulatory requirements.
• Support the preparation, execution, and follow-up of customer, supplier, and regulatory authority audits.
• Plan, perform, and ensure the timely execution of environmental monitoring (re-) mapping studies, including the evaluation, documentation, and reporting of study results.

Kenntnisse

GMP knowledge

Quality documentation

Audit support

Teamwork

German-English communication

Ausbildung

Degree in Chemistry, Pharmacy, Analytical Chemistry, Food Chemistry or comparable

Tools

LIMS

Chromatography data systems

SAP/ERP

Jobbeschreibung

Your responsibilities:

• Support the Sr. Manager QA in all quality related activities within a GMP-regulated environment.
• Ensure the timely review of batch documentation and associated analytical results, and perform the final status assignment or rejection of intermediate and finished products.
• Review, assess, and approve quality-related documents (e.g. manufacturing instructions, analytical procedures, validation and qualification documentation, and Certificates of Analysis (CoAs).
• Ensure compliance with applicable GMP requirements and actively contribute to the continuous improvement of the Quality Management System (QMS).
• Review and manage deviations, change controls, CAPAs, and customer complaints in accordance with internal procedures and regulatory requirements.
• Support the preparation, execution, and follow-up of customer, supplier, and regulatory authority audits.
• Plan, perform, and ensure the timely execution of environmental monitoring (re-) mapping studies, including the evaluation, documentation, and reporting of study results.

Your profile:

• Degree in Chemistry, Pharmacy, Analytical Chemistry, Food Chemistry or a comparable scientific qualification
• Professional experience in Quality Control or Quality Assurance within the chemical or pharmaceutical industry
• Strong knowledge of organic preparative and/or analytical chemistry
• Solid understanding of GMP and ideally other quality systems such as ISO 9001 or GLP
• Experience in batch record review and handling quality-related documentation
• Proficient in MS Office; knowledge of LIMS, chromatography data systems and SAP/ERP is an advantage
• Very good German and good English communication skills, both written and spoken
• Independent, accurate and reliable working style with strong communication and teamwork skills

Your benefits:

• A dynamic working environment with high-quality facilities
• Exciting opportunities to expand your professional knowledge
• At least 5 weeks’ holiday
• Contribution towards childcare costs
• Travel insurance for private travel
• Private accident insurance
• A 13th month’s salary, with 100% of social security contributions covered by CARBOGEN AMCIS
• A profit-sharing bonus is paid following a successful financial year