GxP Compliance Manager

Job title:

GxP Compliance Manager

Company:

Darwin Rhodes

Job description

Job Title: GxP Compliance Manager
Location: Copenhagen, Denmark
Type: ContractPosition Overview:

• Lead Compliance processes for large Pharmaceutical Client
• Lead CSV activities and service assurance testing in-line with requirements of GxP, Annex 11 and SoX
• Manage infrastructure Qualification of hardware/Servers/Infrastructure Apps/Tools.
• Maintains categorization of Off-the-shelf validation categories.
• Leading the effort to create, manage, and/or maintains validation of the GxP computerized systems such as SAP, LIMS, etc
• Provides Qualification/Validation protocol and report oversight.
• Manages the creation of Installation Qualifications, Operational Qualifications and Performance Qualifications and other GAMP 5 document generation.
• Leads or participates in CSV effectiveness and improvement initiatives.

Desired skills / certifications / training:

• 8-10 years’ experience in IT GxP Compliance including deep knowledge of 21 CFR Part 11, Annex 11, PICS
• Strong knowledge of Qualification and Validation project development/implementation processes.
• Pharmaceutical and/or Biotechnology experience including applications, service, facility, and equipment validation experience.
• Knowledge of cGMPs, FDA and EMA guidelines.
• Good oral and written communication skills and teamwork skills.

Expected salary

Location

København

Job date

Wed, 28 Aug 2024 22:27:46 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.