Expert Quality Control (m/w/d)
Firmenname für PREMIUM-Mitglieder sichtbar
- Februar 2023
- Dezember 2023
- D-Frankfurt am Main | D-60306 Frankfurt am Main
- auf Anfrage
- 04.01.2023
- PR-34019219_1672849048
Projekt Insights
Projektbeschreibung
Expert Quality Control (m/w/d)
for:
* Remediation implementation (documented)
* Updated SOPs/work instructions/analytical documents (documented)
Activities
* Apply the Data Integrity regulations as described in Eudralex vol 4., FDA 21 CFR part 11, WHO annex 5 as well as the company guidelines, SOPs, work instructions,
* Document the activities and results as per Good Documentation Practices and compaby guidelines,
* Contribute in equipment qualification (creating documents, performing PQ, ...)
* Adapt and establish documentation with regard to the implementation of the data integrity requirement in instruction documents, manufacturing documents, as well as analytical documents, SOPs
* Updates of excel sheets with regard to current data integrity requirements and defined remediations
* Implement Remediation Activities in the context of company Data Integrity Implementation Program
* Report to the project lead or deputy
Experience
* Average of 2 to 5 years of hands-on GxP experience
* Proven experience in quality control or quality assurance for quality control
* Good Documentation Practice in Pharma and Biotech domains,
* Solid experience with GxP regulations both FDA as well as EU
* English spoken and written
Terms
* Start: Februar 2023
* Duration: till 31/12/2023
* freelance contract, full-time
for:
* Remediation implementation (documented)
* Updated SOPs/work instructions/analytical documents (documented)
Activities
* Apply the Data Integrity regulations as described in Eudralex vol 4., FDA 21 CFR part 11, WHO annex 5 as well as the company guidelines, SOPs, work instructions,
* Document the activities and results as per Good Documentation Practices and compaby guidelines,
* Contribute in equipment qualification (creating documents, performing PQ, ...)
* Adapt and establish documentation with regard to the implementation of the data integrity requirement in instruction documents, manufacturing documents, as well as analytical documents, SOPs
* Updates of excel sheets with regard to current data integrity requirements and defined remediations
* Implement Remediation Activities in the context of company Data Integrity Implementation Program
* Report to the project lead or deputy
Experience
* Average of 2 to 5 years of hands-on GxP experience
* Proven experience in quality control or quality assurance for quality control
* Good Documentation Practice in Pharma and Biotech domains,
* Solid experience with GxP regulations both FDA as well as EU
* English spoken and written
Terms
* Start: Februar 2023
* Duration: till 31/12/2023
* freelance contract, full-time
Kontaktdaten
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