QA Manager IT Validation limited to 2 years (full-time/part-time)(all genders)
A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role :
As a QA Manager IT Validation (all genders) you are a member of the EQ-QV team. In this role you ensure that the selection, implementation and maintenance of GxP relevant computerized systems follow processes that ensure compliance to regulatory requirements and internal standards. You are responsible for the validation of our Group Systems as well as the maintenance of a Validation Master Plan for corporate GxP relevant computerized systems. The review and approval of supplier qualifications regarding validation of corporate computerized systems as well as for GxP assessments of corporate computerized systems are also in the responsibility of the QA Manager IT Validation. You need to corporate GxP audits of computerized systems and definition of CAPAs as applicable. The Implementation and maintenance of Standards and Procedures that define our Quality Strategy regarding corporate GxP relevant computerized systems are included in the daily work, as well as, to ensure compliance with international GxP laws and regulations. Monitor and proactively inform about changes in laws and regulations as well as trends in pharmaceutical industry.
Who you are:
- degree in applied sciences (Chemistry, Biotechnology, Pharmacy), computer science or engineering)
- more than 5 years of experience in a similar role within the pharmaceutical business
- proven track record in qualification and validation of Electronic Systems Qualification (Validation) according to regulations (21 CRF part 11 and EU GMP Annex 11)
- proven experience in leading complex, cross-functional project matrix organizations incl. ability to lead without formal authority
- fluent in English, German a plus
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
Job Requisition ID: 216518 Location: Darmstadt Career Level: D - Professional (4-9 years) Working time model: full-time, part-time possible
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.