Be You at GSKAt GSK, we're a company with a purpose tohelp 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, wewant all applicants tobe able toperform their best throughout the recruitment process.We will be delighted to hear from talented individuals that align toour values.
Theseare at the heart of everything we doand 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 ourInnovation, Performance and Trustpriorities.
In return, GSK commits to providing theright 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 modern employer, we empower you to be yourself, share ideas and work collaboratively.Cleaning Validation ExpertHe/she acts as Validation Subject Matter Expert in the Cleaning Validation area in support of drug product manufacturing (Aseptic operation)He/she executes validation activities and support managers and specialists in activities planning.In this role you will...Responsible for coordinating and/or executing the assigned validation projects/activities, including writing, review documents and raw-data, approval of validation documents and protocols execution as needed.Actively contributes to change control management, investigations, solutions of thevalidation or process deviations and to CAPA implementation.Able to evaluate and assess current practices (batches execution and validation activities) versus regulatory requirements and current industry best practices.Provide training to MPU personnel as part of the cleaning development.Support actively Regulatory Authorities inspection, divisional audits and internal audit (front office is a plus).Provide support for regulatory submissions, participating to the review of the files, for his/her own competency area.Maintain updated his/her training status.Ensure the awareness and respect of safety requirements; ensure adherence to safety SOPs and usage of safety devices.Why youBasic qualifications:
University Degree in scientific field (i.e.
Engineering, Biology, Chemical, Pharmacy) or high school diploma plus at least 2-3 years in pharmaceutical experience.1 or 2 years experience in Validation area.Strong technical skills, including manufacturing systems and control, quality systems, MS Office Applications.Knowledge of guidelines and pharma rules (GxP, ISO, ICH, etc.)
requested by the mainRegulatory Authorities (FDA, AIFA, EMA, etc ).Intermediate EnglishPreferred qualifications:
Risk Management skillsProblem Solving skillsAccountability;Ability to operate cross-functionally and work well within a matrix environment, balance priorities, and handle multiple tasks through good planning, project administration, and organization skills.Inclusion & Diversity at GSK:
Inclusion and diversity at GSK are key for our success.Here, you will thrive through bringing yourunique experiencesto both our company and the recruitment process.
We want you tobe you, feel good and keep growing your career.