QA and Validation Specialist
- Barnard Castle, County Durham (GBR)
- £20 - £26 Per Hour
- 12 Months
- Start date: ASAP
- Ref: GSK0JP00080331
- sops
- compliance
- documentation
- risk management
- quality assurance
- operations
- management
- new product introduction
- change control
- continuous improvement
- project plans
- inspections
Job Purpose
To provide QA and Validation support for New Product Introduction, equipment and facility projects. Provision of technical advice and Quality decision making to establish processes and controls that meet Regulatory, cGMP, and QMS standards. The role will also encompass oversight of Quality Assurance processes within projects e.g. change control, validation documentation, deviation handling, CAPA.
Key Responsibilities
- To support project / product completion in line with established timescales, through collaboration with teams and cross functional stakeholders (R&D, Technical and Quality teams), providing QA compliance leadership, active risk management, and problem solving.
- To contribute to an effective quality assurance and documentation oversight service which ensures that all operations comply with company GMP Standards and Product Quality Specifications. Contributing to the development of processes, review/approval of SOPs and generation/approval of Batch Documents
- Support a continuous improvement culture within the team through the GPS
- Plan validation activities to ensure customer and business needs are met in alignment with the overall project plans and objectives; accountable for the validation and validation maintenance for Processes, Facilities, Equipment, and simple CSV systems
- Excellent interpersonal skills, including the ability to work across the organization, forming strong partnerships (on and off site) at a technical level, and interact/influence/negotiate effectively at all levels of management and peers.
- Ability to work well under pressure with tight timelines
- Ability to analyse complex data / information / scenarios and make rational, risk based decisions which are communicated and / or escalated clearly and confidently
- Knowledge and understanding of the QMS
- Supports Level 1 self-inspections
About You:
This role would suit a driven and motivated individual who has strong experience of working in a complex operational environment. Strong people-management skills and experience, as well as a proven ability to drive performance, are considered essential. It is imperative in this role that you demonstrate an ability to drive common-objective thinking, with a complete focus on providing solutions. You will need to be persuasive, have a strong continuous improvement mindset, and have proven experience of dealing with diverse internal and external stakeholder groups. Ideally you will have worked in a highly regulated-industry (experience of the provision of complex facilities support services to a large office or pharmaceutical facility would be highly advantageous).
About GSK:
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world. For more information on GSK please refer to our website: www.gsk.com
GSK’s Worldwide Real Estate and Facilities (WREF) deliver the right space in the right location, and at the right cost, with industry competitive and customer focused services. The organisation oversees and operates circa 16 million square feet of space with a population of over 28,000 GSK and other staff, including all pharmaceutical and consumer health R&D laboratories and pilot plants, as well as commercial office accommodation for all GSK business units. This portfolio of property currently requires an annual spend of more than £450m in operating costs and £200m in capital investment.
