CSV Specialist

Location: Dudley, Northumberland, UKDepartment: QualityReference: VN230
Summary of the Computer System Validation (CSV) Specialist role

As the CSV (Computer System Validation) Specialist you will report directly to the Head of Data Integrity and CSV/CSA Compliance and be the subject matter expert responsible for implementing Computer System Validations at our site in Cramlington.

Your normal working hours will be 37 hours per week Monday-Friday with the flexibility of hybrid working.

 Your responsibilities
 
  • Championing 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.
  • Validating manufacturing, laboratory and other business systems.
  • 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.
  • Authorising 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.
 
Requirements for the role
 
  • 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 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.
 
How you will be rewarded

We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Perkbox, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.

Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.


How to apply

If you have the necessary skills and experience to join our team, please apply online.  For any queries or should you require any reasonable adjustments to support your application please contact recruitment@sterlingpsl.com

Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.
 
Be caring. Be transparent. Be willing. Be reliable.
Deadline for applications: 21 Aug 2022