Treffen Sie AbbVie auf der T5 JobMesse
Process / Cleaning Validation Project Manager (f/m)
To coordinate the development and maintenance of the company’s validation program in compliance with all applicable
regulatory and AbbVie requirements.
- Managing, co-ordination, implementation and active participation in the site Validation Program
- Ensuring team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines as all times.
- This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned.
- Responsible for presenting and taking ownership of own area during regulatory inspections and corporate audits
- Ensures all procedures/policies and guidelines are in compliance
- This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
- Supporting Bulk Manufacturing and the site KPI’s
- Ensure all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
- Co-ordination / direction and active participation in the validation of site equipment,facilities, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.
- Generation/maintenance of the Validation Master Plans.
- Generation/maintenance of Project Validation Plans.
- Generation of validation protocols and final reports to cGMP standard.
- Review / approval of all protocols and final reports.
- Management of validation change control process.
- Adheres to and supports all EHS standards, procedures and policies
- Is a site SME on all Validation issues and provides guidance on same
We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.
- Pharmacist, Engineer (Master, Dipl Ing)
- 3-5 years experience in pharma environment, especially manufacturing
- Experience working in a cGMP environment. Familiarity with the Regulatory and QA issues surrounding the manufacture
- Experience in Product Development, CTS or supervisory experience in a busy production environment
- Judgement, initiative, concern for excellence, providing direction, technical skill & competence, teamwork & Problem analysis, driving the business
- Good communication and motivation ability is required
- Strong written and verbal communication skills
- Fluency in English is requirement in order to communicate with required colleagues globally
AbbVie is characterized by diversity and internationality. We therefore welcome diversity among our applicants, in
particular also chronically ill and severely disabled people.