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Regulatory Coordinator
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Client, Support
Projektbeschreibung
One of our clients, a multinational company in the pharmaceutical industry currently requires a Regulatory Coordinator with min 5 years experience in the pharmaceutical industry
Start: ASAP
Length: min 6 months
Location: South of Brussels
Our client is conducting a compliance assessment program (CMC compliance review) that includes the following:
* The alignment between the QC methods filed as compendial versus those actually in place and in use in QC laboratories, referred to as the compendial gap analysis,
* The alignment of the dossier registered details with the current documentation in QC and Manufacturing Operations, referred to as the gap analysis.
The compendial gap analysis, performed as a first step of the compliance assessment program, is finalized.
The regulatory remediation is ongoing (around 15 variations to be submitted 1Q 2014, for which a group of 15 contingent workers has beenestimated to support these activities).
Our client is also conducting a broader gap analysis to compare the registered details to what is performed in manufacturing operations and testing laboratories.
The proposed methodology for conducting identification and remediation of differences between File and Operations is based on a product by product approach.
The regulatory remediation is planned for beg next year for the first product family.
TASKS:
- The coordinator should lead the team of CMC writers and registration managers in accordance with the planning.
- She/he should ensure the preparation and submission of the different regulatory vairations worldwide.
Tags: Regulatory, Compliance, Pharmaceutical, QC, Pharmaceutique
Start: ASAP
Length: min 6 months
Location: South of Brussels
Our client is conducting a compliance assessment program (CMC compliance review) that includes the following:
* The alignment between the QC methods filed as compendial versus those actually in place and in use in QC laboratories, referred to as the compendial gap analysis,
* The alignment of the dossier registered details with the current documentation in QC and Manufacturing Operations, referred to as the gap analysis.
The compendial gap analysis, performed as a first step of the compliance assessment program, is finalized.
The regulatory remediation is ongoing (around 15 variations to be submitted 1Q 2014, for which a group of 15 contingent workers has beenestimated to support these activities).
Our client is also conducting a broader gap analysis to compare the registered details to what is performed in manufacturing operations and testing laboratories.
The proposed methodology for conducting identification and remediation of differences between File and Operations is based on a product by product approach.
The regulatory remediation is planned for beg next year for the first product family.
TASKS:
- The coordinator should lead the team of CMC writers and registration managers in accordance with the planning.
- She/he should ensure the preparation and submission of the different regulatory vairations worldwide.
Tags: Regulatory, Compliance, Pharmaceutical, QC, Pharmaceutique
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
IT Entwicklung, Sonstiges