détails du poste
For our client Merck in Aubonne, we are looking for a QA Specialist for QC (m/f/d) for a period of 12 months.
Your role:
To ensure the quality oversight and compliance of QC activities and the data integrity of QC analytical data in timely manner.
- QA Oversight on QC analytical data:
To perform the QA review on QC analytical data, on QC documentation.
Manage QC deviation, CCP and CAPA as QA.
- Compliance of QC activities:
QA support for QC activities including new guidelines, new pharmacopeias versions. Support the implementation of all QC projects.
To perform Quality on the Floor for QC operations.
- Digitalization/Process Improvements
Propose and implement digitalized and more efficient solutions to improve processes in place within the department.
Each team member is the reference point of contact for one laboratory. Members of the team are backing-up each other in case of absence as long as they are trained to the concerned activities.
- Participation in inspections
Participate in Health authorities and internal inspections as Subject Matter Expert and support QC laboratories during inspections.
Participate in inspection readiness planning meetings to prepare inspections.
Implement appropriate CAPA plan after inspection.
Your profile:
- Chemistry, biology or pharmacy master degree with minimum 3 years of experience in Pharmaceutical industry.
- Experience in Quality Assurance. Quality Assurance operation is a plus.
- Expertise in cGMP best practices.
- Experience in analytical analysis is a plus.
- Good knowledge on laboratory equipment and software (like Glims, Empower, Disco…) is a plus
- Fluent in French and English
- Having a team spirit and being collaborative are essential.
For our client Merck in Aubonne, we are looking for a QA Specialist for QC (m/f/d) for a period of 12 months.
Your role:
To ensure the quality oversight and compliance of QC activities and the data integrity of QC analytical data in timely manner.
- QA Oversight on QC analytical data:
To perform the QA review on QC analytical data, on QC documentation.
Manage QC deviation, CCP and CAPA as QA.
- Compliance of QC activities:
QA support for QC activities including new guidelines, new pharmacopeias versions. Support the implementation of all QC projects.
To perform Quality on the Floor for QC operations.
- Digitalization/Process Improvements
Propose and implement digitalized and more efficient solutions to improve processes in place within the department.
Each team member is the reference point of contact for one laboratory. Members of the team are backing-up each other in case of absence as long as they are trained to the concerned activities.
- Participation in inspections
Participate in Health authorities and internal inspections as Subject Matter Expert and support QC laboratories during inspections.
Participate in inspection readiness planning meetings to prepare inspections.
Implement appropriate CAPA plan after inspection.
Your profile:
- Chemistry, biology or pharmacy master degree with minimum 3 years of experience in Pharmaceutical industry.
- Experience in Quality Assurance. Quality Assurance operation is a plus.
- Expertise in cGMP best practices.
- Experience in analytical analysis is a plus.
- Good knowledge on laboratory equipment and software (like Glims, Empower, Disco…) is a plus
- Fluent in French and English
- Having a team spirit and being collaborative are essential.
