We are seeking a skilled and experienced CSV Compliance Specialist to join our team. The CSV Specialist will be working in the Digital Solutions team under the supervision of the Head of Enterprise Applications and the Henka Programme Manager.
He/she will work closely together with the GC Global SAP team members, Digital Solutions team, globally located Business Process Experts (BPEs), end users, externally hired contractors, the SAP partner and SAP.
Health Insurance/HMO
Enjoy unlimited MadMax Coffee
Diverse learning & growth opportunities
Accessible Cloud HR platform (Sprout)
Above standard leaves
Developing validation documentation for a leading oral health company, supplying world-class quality products and services to all dental professionals worldwide.
Full lifecycle validation for all applicable computerised systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance.
Analyzes, reviews and approves change controls
Working with project teams to compile user requirements for local and group software systems.
Carrying out risk assessments and periodic reviews throughout system lifecycles to ensure systems are maintained in a validated state during their operational life.
Using quality risk management to deliver scalable approaches to CSV.
Authorizing validation plan deliverables and CSV COPs / policies.
Writing test plans / scripts and carrying out documented black box testing throughout systems lifecycles.
Participating in Performance Qualification (PQ) and User Acceptance Testing (UAT) ensuring that the appropriate documentation of testing is performed.
Working with system vendors to leverage appropriate information and documentation into Sterling CSV activities.
Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles.
Keeping up to date with advances in the CSV field, regulatory requirements and good practice guidance.
Working with process owners to identify and implement new systems and upgrade existing systems to aid improvements to compliance and reduce risks to patient safety, product quality and data integrity.
Participating in both internal and external audit inspections from a CSV perspective.
Delivering compliant validated systems by design.
Supporting system administrators and the Training & Development department in training employees on the correct use of computerised systems in line with procedures and regulations.
Embodying our company values, which are: be reliable, be caring, be transparent and be willing.
Degree/post-graduate education or experience in Chemistry or life science subject.
Previous experience of working in the life sciences industry (e.g. Pharmaceutical/Biotechnology) in Quality function.
In depth knowledge of ISO 13485 and other related international standard for quality management systems (QMS) specifically for the medical device industry
In depth knowledge of GAMP5 and a broad understanding of validation principles in general.
Good knowledge of FDA / MHRA and other governing bodies regulations and requirements for GxP, data integrity and data governance.
ISTQB testing qualification and or experience desirable.
FDA 21 CFR Part 11, EU Annex 11 knowledge and application.
Must have strong communication skills and the ability to pull together metrics, reporting and presentations.
Professionalism required to present to senior stakeholders within the organisation.
A relentless focus on eliminating waste to increase value for our stakeholders is the core of our continuous improvement approach.
Strong self-motivation with the ability to work with minimum supervision.
Must be able to manage conflicting priorities, whilst being extremely adaptable, agile and flexible.
Detailed orientated, ability to multi-task and manage multiple deadline-orientated projects is essential.
Strong written and verbal communication, highly organised with a focus on delivering business results.
Excellent time management and projects management skills.
Ability to build trust and credibility with stakeholders