Specialist QA Csv
il y a 2 semaines
**_Be You’ at GSK _**:
At GSK, we're a company with a purpose to **help people do more, feel better and live longer. **We realise that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.
We will be delighted to hear from talented individuals that align to **our values. These **are at the heart of everything we do and include**:Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.**
**When you set out on your adventure at GSK, we make a deal. **You commit to living our values and expectations and performing against our **Innovation, Performance and Trust **priorities. In return, GSK commits to providing the **right environment for you to thrive. **Together, we build an environment where we can all thrive and focus on what matters most to each of us.
As a, we empower you to be yourself, share ideas and work collaboratively
**_ Specialist QA CSV _**:
**In this role you will **
- Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerised systems
- Writing, reviewing and approving of Validation Plans (VP)
- Writing, reviewing and approving of Validation Summary Reports (VSR)
- Reviewing and approving of design documentation (TCD, ERES, URS, DQ,...)
- Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
- Writing and reviewing of Periodic Review Reports (PR)
- Reviewing and approving of CSV specific documentation (inventory,...)
- Ensure QA activities on quality systems (CAPA, Deviation, Change Control,...) related to automated and computerised systems.
- Manages the workload related to his area of responsibility (project, MPU, automation team, cluster,...) as required by site priorities.
- Support team and management during internal and external audits
**_ This job opportunity is a permanent contract _**_not_**_ opened for relocation._**
**_ Why you? _**
Qualifications & Skills:
- Master's degree in Engineering, Sciences, Automation
- Minimum 3 years of experience in a computer systems validation role in a pharmaceutical environment.
- Fluent in French & English
Preferred Qualifications & Skills:
- CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11,)
- Validation practices and guidelines (life cycle approach, ICH, ASTM E2500,)
- Autonomy
- Team player
- Problem solving skills
- Autonomy
- Li-GSK
GSKTechTalent
**_ Why GSK?_**:
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.
**GSK Vaccines** - Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries.
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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