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.
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.
The successful candidate will be able to contribute to the definition of the validation approach, review and approve all the validation and change control documentation to ensure it is compliant with regulatory and company expectations.
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 Integrity Guidance, MHRA Data Integrity 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 CLOSING DATE for applications: December, Friday 20th. We will be accepting applications up until the closing date, however, please note that we will be processing applications and scheduling interviews during the advertising period. Your application would be welcomed as soon as possible.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
The position offered will reflect the actual competence and experience gained by the identified candidate, in relation to the responsibilities of the proposed role.
Internal candidates can apply through the My Job Opportunities section in Workday. Applications will only be considered if the candidate has been in the current position for at least 12 months. We remind you that it is necessary to inform your manager when you are called for the selection interview.
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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
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.
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