CSV & Systems Officer

Sciensus Pharma Services Limited; Burton upon Trent; Vor Ort; GBP 35.000 - 55.000; Vollzeit

Benefits dieser Stelle

25 days annual leave + bank holidays

Yearly pay reviews

Life Assurance

Annual company event

Refer a friend scheme

Pension scheme

Private medical (BUPA)

Salary sacrifice schemes

Discount & cashback portal

Training opportunities

Well-being initiatives

Volunteer day

Zusammenfassung

Sciensus Pharma Services Limited in Burton upon Trent seeks a CSV & Systems Officer to own validation of computerised systems and electronic quality management systems, ensuring patient safety, product quality and regulatory compliance.

You will lead validation activities, administer access, support upgrades, and deliver reports while supporting continuous improvement in a GMP environment with cross-functional teams.

Qualifikationen

• Degree in Science, Pharmacy, Computer Science, Quality Assurance or a related discipline.
• Experience of Computer System Validation (CSV).
• Experience administering quality management systems or other regulated IT systems.
• Experience working within a GMP-regulated environment.
• Experience writing and reviewing validation documentation.
• Experience managing change controls and risk assessments.
• Knowledge of EU GMP Annex 11, GAMP 5, Data Integrity/ALCOA+ and Quality Management Systems.
• Validation lifecycle management.

Aufgaben

• Developing, executing and maintaining validation documentation including Validation Plans, URS, Risk Assessments, IQ, OQ and PQ protocols.
• Administering electronic quality systems, including user access management, permissions and periodic account reviews.
• Supporting system upgrades, enhancements, testing activities and software releases.
• Ensuring compliance with EU GMP Annex 11, GAMP 5 principles and Data Integrity requirements.
• Managing system-related change controls, risk assessments, deviations and CAPAs.
• Supporting regulatory inspections, customer audits and supplier assessments.
• Delivering user training, creating guidance materials and providing first-line systems support.
• Producing compliance reports, KPIs and system performance metrics.
• Driving continuous improvement, digitalisation and automation initiatives across the site

Kenntnisse

CSV experience

QMS administration

Validation docs

Regulated IT

Stakeholder management

Attention to detail

Ausbildung

Degree in Science/Pharmacy/CS/QA

Tools

eQMS software

Jobbeschreibung

Burton on Trent, Staffordshire, United Kingdom

Our mission at Sciensus is simple: to give patients control of their health through knowledge, choice, convenience and connection.

To help us be successful in our mission we are looking for a CSV & Systems Officer

40 hours per week / Site-Based / Perm Contract

This is an exciting opportunity to take ownership of our Computer System Validation (CSV) activities and electronic quality systems that play a critical role in patient safety, product quality and regulatory compliance. Working closely with colleagues across Quality, Operations and IT, you'll have the opportunity to drive continuous improvement, support digitalisation projects and help shape the future of quality systems within the business

You will lead and support the validation, administration and continuous improvement of GMP computerised systems and electronic quality management systems (eQMS). Key responsibilities will include:

• Developing, executing and maintaining validation documentation including Validation Plans, URS, Risk Assessments, IQ, OQ and PQ protocols.
• Administering electronic quality systems, including user access management, permissions and periodic account reviews.
• Supporting system upgrades, enhancements, testing activities and software releases.
• Ensuring compliance with EU GMP Annex 11, GAMP 5 principles and Data Integrity requirements.
• Managing system-related change controls, risk assessments, deviations and CAPAs.
• Supporting regulatory inspections, customer audits and supplier assessments.
• Delivering user training, creating guidance materials and providing first-line systems support.
• Producing compliance reports, KPIs and system performance metrics.
• Driving continuous improvement, digitalisation and automation initiatives across the site

What's in it for you?

• Opportunity to work in a highly regulated healthcare environment where your work directly supports patient safety.
• Exposure to a broad range of quality systems, validation activities and regulatory requirements.
• Involvement in exciting digitalisation and process improvement projects.
• A collaborative team environment focused on quality, compliance and continuous improvement.
• Professional development and career growth opportunities within an expanding healthcare organisation.

What’s required to be successful?

We're seeking a quality-focused professional who combines strong technical knowledge with excellent communication and stakeholder management skills.

• Degree in Science, Pharmacy, Computer Science, Quality Assurance or a related discipline.
• Experience of Computer System Validation (CSV).
• Experience administering quality management systems or other regulated IT systems.
• Experience working within a GMP-regulated environment.
• Experience writing and reviewing validation documentation.
• Experience managing change controls and risk assessments.
• Knowledge of:
• EU GMP Annex 11
• GAMP 5 methodology
• Data Integrity and ALCOA+ principles
• Quality Management Systems
• Validation lifecycle management
• Strong attention to detail and excellent document writing skills.
• Ability to manage multiple priorities and projects simultaneously

Why work for Sciensus?

Sciensus is a leading European life sciences organisation with over 30 years of experience, helping over 240,000 patients a year gain access to beneficial treatments and life-changing medicines.

We empower patients with digital tools to take control of their treatments, report on symptoms, quality of life, and access support through their care journey. We blend this with personalised support services from our team of over 700 registered clinical staff.
Every colleague at Sciensus contributes to improving the patient experience. Whether you're supporting operations behind the scenes or delivering care directly to patients, your work makes a real difference.

What we offer our people?

We work hard to make sure colleagues feel motivated, developed, and recognised for the great work they do. This role offers a competitive salary alongside a comprehensive benefits package, including:

• 25 days annual leave + bank holidays
• Yearly pay reviews.
• Life Assurance
• Annual company event.
• Refer a friend scheme.
• Contribution based pension scheme.
• Access to BUPA private medical (Subject to grade or length of service)
• Salary sacrifice schemes (Electric vehicle/Bike to work/Tech)
• Discount & cashback portal.
• Internal & External training opportunities
• Access to various well-being initiatives
• Paid volunteer day

At Sciensus, our values shape who we are, what we stand for and how we work every day. We're Passionate about Patients, putting patient care and experience at the heart of every decision we make. We're Ambitious to be the Best, continuously learning, improving and innovating to deliver exceptional outcomes. And we believe Together, We Win, building trusted relationships, embracing diverse perspectives and achieving more through collaboration.