Darwin Rhodes
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.