Job
- Level
- Experienced
- Job Field
- IT, System, Test/QA
- Employment Type
- Full Time
- Contract Type
- Temporary employment
- Location
- Starnberger See, Munich
- Working Model
- Hybrid, Onsite
Job Summary
In this role, you will enhance Data Integrity processes, analyze systems, support validation according to relevant standards, while coordinating risk management and CAPA actions.
Job Technologies
Your role in the team
- Maintenance and further development of existing Data Integrity processes and strategies.
- Coordination and support of the involved departments in analyzing existing facilities, systems, and processes.
- Support in the definition and implementation of potential CAPA measures and in change management processes.
- Conducting validations of computer-based systems and software in accordance with DIN EN ISO 13485, 21 CFR Part 820, 21 CFR Part 11, GAMP 5, and EU-GMP guidelines.
- Creation, review, and approval of validation documents.
- Conducting process-related and validation-related risk analyses (initiation, documentation, moderation).
- Participation in the development and maintenance of the Validation Master Plan.
- Coordination of the persons involved in validation and their activities within the scope of validation execution.
- Answering questions related to Data Integrity and validation topics within the scope of audits.
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Our expectations of you
Education
- Completed technical training or a technical degree and several years of professional experience in the pharmaceutical or medical technology industry.
Qualifications
- Proficient in MS Office.
- Very good German and English, both written and spoken.
- Emotional maturity, strong communication skills, persuasiveness, and a high degree of initiative.
Experience
- Knowledge or experience with Data Integrity principles (ALCOA+).
- Experience in the validation of computer-based systems and software in a GxP-regulated environment, ideally also with ERP systems, databases, and GAMP Category 5 software.
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What we offer
- Exciting tasks in a globally operating medium-sized company.
- Dynamic work environment, flat hierarchies, and high value creation depth.
- Flexible working hours plus the option to work remotely.
- Diverse training opportunities.
- Health management, digital sports sessions, group accident insurance.
- Childcare allowance, corporate benefits, free charging options for electric vehicles.
- Individual onboarding.
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Benefits
Work-Life-Integration
Health, Fitness & Fun
Job Locations
This is your employer
PARI GmbH
The PARI Group is based in Starnberg and has additional locations in Weilheim and Gräfelfing. There are also international branch offices and a worldwide distribution network. The approximately 500 employees and stable management team, can look back on the company’s history of more than 100 years in business.
Description
- Company Size
- 250+ Employees
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Industry, Production
Data Integrity Specialist
- Location
- Starnberger See, Munich
- Working Model
- Hybrid, Onsite
- Diversity
- Open for all genders
