Pharma Digital Compliance Specialist

1 mese fa

Parma, Italia GSK A tempo pieno

**Site Name**: Italy - Parma

**Posted Date**: May 10 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 Digital Compliance Specialist (Digital & Robotics Solutions) will be responsible for overseeing compliance with regulatory requirements and industry standards related to digital technologies and robotics within pharmaceutical manufacturing. This role requires expertise in digital compliance, validation principles, and robotics systems to support the implementation, and validation of advanced manufacturing solutions.

**In this role, you will**
- Develop and implement digital compliance strategies, and procedures to ensure adherence to regulatory requirements, including FDA regulations, EU Annex 11, GAMP 5, and other applicable guidelines.
- Collaborate with cross-functional teams, including manufacturing, quality assurance, IT, engineering, and regulatory affairs, to design, implement, and maintain compliant digital and robotics solutions in manufacturing operations.
- Lead the validation efforts for digital and robotics systems, including risk assessments, validation plans, protocols (IQ, OQ, PQ), and validation reports, ensuring data integrity and system reliability.
- Conduct regular audits and assessments of digital and robotics systems to identify compliance risks, data integrity issues, and deviations from established procedures.
- Provide training and guidance to manufacturing personnel on the proper use of digital and robotics solutions, compliance requirements, and best practices.
- Ensure accurate documentation of validation activities, deviations, corrective actions, and change control records for digital and robotics solutions.

**_ Why YOU?_**:
**Qualifications and Skills**:

- Bachelor's degree in a relevant field, such as engineering, pharmaceutical sciences, computer science, or related discipline
- Proven experience in a compliance or quality role within the pharmaceutical manufacturing industry, with a focus on digital technologies and/or robotics solutions.
- Strong understanding of regulatory requirements, guidelines, and standards related to digital records, electronic signatures, cybersecurity, and robotics systems in a GMP environment.
- Experience with digital manufacturing solutions, such as Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and robotics automation platforms.
- Proficiency in computer systems validation (CSV) principles, risk assessment methodologies, and validation documentation practices.
- Familiarity with data integrity concepts, including ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.

**Preferred Qualifications and Skills**:

- Advanced degree or certification in regulatory affairs, quality assurance, or compliance is preferred.
- Excellent analytical, problem-solving, and project management skills, with a meticulous attention to detail.
- Effective communication and interpersonal skills, with the ability to collaborate and influence stakeholders at all levels of the organization.
- Ability to work independently, prioritize tasks, and thrive in a fast-paced, regulated environment.
- Knowledge of robotics technologies, automation principles, and equipment validation processes is a plus.

**Job posting end date: Friday, May 24th**

**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 ex

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