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SIRE Life Sciences®

Associate Compliance


SIRE Life Sciences®

Associate Compliance

Location: Netherlands
Associate Compliance

The company
This company is a biotechnology pillar of the world, committed to transforming new ideas and discoveries into medicines to treat serious diseases. Its goal is to create innovative medicines, provide transformative research, and high-quality treatment worldwide.

Role Description

As an Associate Compliance you will be responsible for manage temperature excursions, minor and major deviations, CAPAs and CAPA EVs that are reported in the EMEA region and to assist in various projects with related to continuous improvements and GDP topics across the organization.

Responsibilities
 - Own and manage temperature excursion records.
- Own and manage minor and major deviation records and lead root cause analysis sessions.
- Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
- Support activities for product recall or annual mock recall exercises.
- Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.
- Support activities related to GDP-process improvements.


Requirements
 - Bachelor’s degree or equivalent in Life Sciences or 2 years’ experience in GMP / GDP compliance
- Experience in GMP / GDP compliance
- Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
- Fluency in English
- Strong word processing, database and spreadsheet application skills and digital tools


Other Information 
Are you interested and want to apply for this role, feel free to contact me.



 
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SIRE Life Sciences®

Job Description

Associate Compliance

The company
This company is a biotechnology pillar of the world, committed to transforming new ideas and discoveries into medicines to treat serious diseases. Its goal is to create innovative medicines, provide transformative research, and high-quality treatment worldwide.

Role Description

As an Associate Compliance you will be responsible for manage temperature excursions, minor and major deviations, CAPAs and CAPA EVs that are reported in the EMEA region and to assist in various projects with related to continuous improvements and GDP topics across the organization.

Responsibilities
 - Own and manage temperature excursion records.
- Own and manage minor and major deviation records and lead root cause analysis sessions.
- Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.
- Support activities for product recall or annual mock recall exercises.
- Maintain data accuracy and perform data analysis for Management reviews of the quality system on a periodic basis.
- Support activities related to GDP-process improvements.


Requirements
 - Bachelor’s degree or equivalent in Life Sciences or 2 years’ experience in GMP / GDP compliance
- Experience in GMP / GDP compliance
- Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.
- Fluency in English
- Strong word processing, database and spreadsheet application skills and digital tools


Other Information 
Are you interested and want to apply for this role, feel free to contact me.



 

Additional Information

Last updated
Employment type
Full time
Contract type
Permanent
Number of vacancies
1
Min. experience
One year
Min. education
High School
Industry / category
Jobs in Laboratory / Biotechnology / Pharmacy