QA Validation Specialist
1 settimana fa
**Site Name**: Italy - Parma
**Posted Date**: Dec 6 2024
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage _Life at GSK | GSK_
The purpose of this role is to ensure that Validation activities and Change Controls related to equipment, digital and computerized systems are managed in accordance to GSK QMS and validation procedures requirements.
**In this role, you will**
- Be responsible for the management of QA activities related to Change Control and Validation
- Ensure that validation activities are carried out in accordance with the GSK validation methodologies
- Write, review and approve Validation Plans and Validation Reports.
- Review and approve IQ, OQ and PQ protocols and reports
- Write, support and approve Data Integrity, Data Process Mapping and Audit Trail Review assessments
- Act as SME for deviations and CAPAs
- Train business and technical users involved in Validation activities on GSK validation methodologies and Data Integrity requirements
- Participate as SME to internal, supplier and regulatory Audits
**Why YOU?**:
**Qualifications and Skills**:
- University graduate or equivalent in a technical area (Engineering, Computer Science, Chemistry)
- Experience in the pharmaceutical industry in technical or quality roles
- Good knowledge of basic GMP requirements, CFR 21- Part 11, Eudralex Vol. 4 Annex 11, FDA Data Integity Guidance, MHRA Data Integity Guidance
- Upper Intermediate English language
**Preferred Qualifications and Skills**:
- Experience in computer system validation in the pharmaceutical industry (3 years+)
- Good knowledge of Digital systems (eBRS, LIMS)
- Good knowledge of major computerized systems: SCADA, Laboratory Equipment
- Good knowledge of major systems: Autoclaves, Freeze Dryers, Fillers, HPLCs
- Strong relationship management building skills, with the ability to interact, influence, and manage multiple and varied business contacts, both internal and external, often with different requirements and goals
- Advanced Intermediate English language
**What we offer**:
- Permanent contract in a very Inclusive environment
- Smart Working up to 50% for eligible roles
- Flexible Benefits
- Company Healthcare Plan
- Integrative pension fund
- Employee Assistance Programme
- Sustainable mobility programme
- Company canteen
- Performance Reward
Please take a copy of the Job Description, as this will not be available post closure of the advert.
**Why GSK?**
**Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
**Important notice to Employment businesses/ Agencies**
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and stat
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