New Regulatory Affairs Associate QMS Manager - Global PV Operations - Home working available (Code NL 260620)

Reference: OD10525A

Expiry Date: 26-12-2020

Categories Biotech, Clinical Research, R & D

Salary: Competitive

Job Type: Contractor

Location:
Amsterdam
Netherlands

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Job Description

New Regulatory Affairs Associate QMS Manager - Global PV Operations - Home working available

Location: Netherlands

We have a new Regulatory Affairs Associate QMS Manager contractor role for global Pharmaceutical Company with home working options available.

You will be operating in the Global Pharmacovigilance in the Regulatory Affairs department for the Global PV operations in support of global Audit and Inspection readiness with a focus on process, compliance metrics and KPIs and the maintenance of the controlled safety documents (SOP WPD).

Responsibilities:

  • Ensure continuous monitoring on compliance, quality metrics, and timelines while working in close collaboration with internal/external stakeholders (Global PV, JP and EU-QPPVs, RA, QA);
  • Coordinate and support where needed the preparation of audit/inspection responses, and harmonizes the preparation of GPV Corrective and preventive action plans and deviations; provide guidance and support to the GPV functions on the administrative process and evidence collection;
  • Assemble and organize requests for improvement of GPV business processes within the global team, supporting the implementation of new legislation into quality documents;
  • Facilitate the review and approval process of cross-functional SOPs, and WPDs that involves Global PV work- related responsibilities. Support global PV staff of approximately 200 individuals by offering consultation, advice, and subject matter expertise and assists with Regulatory inspection management activities.

The rate is very good and the projects are interesting and the team in International and extremely friendly.  The contract will last 6-12months.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Octavian Dinca on +44 (0)207 801 3387 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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