Batch Record Reviewer and Support Specialist
Swisslinx
Auf einen Blick
- Veröffentlicht:25 Oktober 2024
- Pensum:100%
- Vertrag:Festanstellung
- Sprache:Englisch (Fliessend)
- Arbeitsort:Upper Valais
On behalf of our client, a leading international biotechnology company, Swisslinx is looking for a Batch Record Reviewer and Support Specialist. In this role, you will ensure the accuracy and compliance of critical batch records in a fast-paced, GMP-regulated environment, collaborating closely with operations and QA teams to drive smooth and efficient product release.
Contract type - Contract
Start Date - November
Location - Visp
Workload - 100%
Duration - initiall 6 months (until May 2025)
Your Mission:
* Review of the executed electronic Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures (HEPT, FIT), Autoclave and Washing machine protocols, used material, calibration records, sample results recorded in LIMS, logbooks, etc.)
* Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
* Initiate and support accomplishment of Deviations and investigations for Batch Record review related observations
* Support the initiation of CRs and TCRs
* Support preparation of documentation package to enable fast release by QA
Your Background:
* Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
* Ability to identify non-compliance and gaps from quality standards
* Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation
* Structured, focused and well-organized working attitude
* Open-minded for new ideas and suggestions; solution-oriented
* Agile, highly motivated and dynamic drive
* Ability to produce reliable results under stress
* Knowledge of MES Syncade, DeltaV system (preferably)
* Fluent in English (German basic knowledge is an advantage)
What's on offer
* An initially 6 month contract.
* A great opportunity to develop your career at a leading international biotechnology company.
* A competitive salary.
If this sounds like you, don't hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
Contract type - Contract
Start Date - November
Location - Visp
Workload - 100%
Duration - initiall 6 months (until May 2025)
Your Mission:
* Review of the executed electronic Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures (HEPT, FIT), Autoclave and Washing machine protocols, used material, calibration records, sample results recorded in LIMS, logbooks, etc.)
* Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
* Initiate and support accomplishment of Deviations and investigations for Batch Record review related observations
* Support the initiation of CRs and TCRs
* Support preparation of documentation package to enable fast release by QA
Your Background:
* Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
* Ability to identify non-compliance and gaps from quality standards
* Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation
* Structured, focused and well-organized working attitude
* Open-minded for new ideas and suggestions; solution-oriented
* Agile, highly motivated and dynamic drive
* Ability to produce reliable results under stress
* Knowledge of MES Syncade, DeltaV system (preferably)
* Fluent in English (German basic knowledge is an advantage)
What's on offer
* An initially 6 month contract.
* A great opportunity to develop your career at a leading international biotechnology company.
* A competitive salary.
If this sounds like you, don't hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
Kontakt
Swisslinx