Data Integrity

2 months ago

Petersfield, United Kingdom Workshop Recruitment Full time

**Data Integrity & Validation Lead**

**Full-time, permanent, 8:15-16:30 Mon-Fri**

**Petersfield**

**£58k - £64k**

**Description**

Our client is one of the world's leading manufacturers and marketers of quality skin care, makeup, fragrance and hair care products, currently looking to fill the position of Data Integrity & Validation Lead to join an experienced and committed team.

**Key Responsibilities and process workload includes**:

- Lead DI Rollout strategy for plant.
- Direct the efficient and effective execution of DI requirements across the site/campus
- Liaise with relevant cross-functional team (DI Site program managers globally, manufacturing sites, R&D, IT, other) to coordinate DI activities to leverage scale and maximize efficiencies
- Collaborate with other DI Site Leads to share best practices and harmonize processes across the global manufacturing sites
- Initiate and manage any DI work processes required for assigned program (including Change Management) to ensure site compliance
- Resolve timeline issues related to executional deliverables and develop tactical plans when necessary to bring back on track
- Ensure Day to Day discipline to project plan and call out any risk of timeline gaps
- Ensure implementation of continuous improvement and process improvement programs
- Establish current state and work to drive remediation efforts and sustainable solutions
- Manage the DI compliance on all GxP Computerized Systems - Instruments and Equipment
- Lead and manage the effective execution and implementation of computerized projects across the entire site including QA Labs
- Ensure adherence to System Development and Life cycle (SDLC), FDA Validation, CFR 21 Part 11 and Change Control management processes requiring a detailed knowledge of the Quality Systems inclusive of Change Control, CAPAs and Deviation procedures.
- Provide oversight to site functional teams to ensure they maintain compliance with all documented validation policies and procedures within the plant.
- Increase the level of compliance in production without sacrificing a pragmatic approach, particularly regarding procedures and policies.
- Provides advice in the introduction, coordination, monitoring and analysis of validation and compliance processes.
- Develop and implement validation and DI processes across the full scope of manufacturing operations and building systems.

**Qualifications**
- Experience in staff management with proven ability to manage and collaborate in a multi-location, multi-vendor environment with an emphasis on process documentation and training.
- Must be an excellent team player with strong analytical skills, negotiating and communication skills
- Strong program management skills including follow-up and organizational skills
- Ability to use computer systems necessary to meet objectives including Microsoft Office, MS project, SAP
- Experienced in Supply Chain processes and working across multiple business functions at site level to rollout DI and validation requirements. Aiming to ensure excellence in execution with the technical community of the Supply Chain.
- Strong ability to provide visibility and management of priorities and risks and opportunities for DI and validation related activities and elevated to leadership where appropriate.
- Strong background working with corporate functions - such as Global R&D and Global QA - to ensure robust SOPs and Work Instructions are in place to ensure compliant GxP systems.
- Experienced in writing SOPs and Work Instructions and other Quality System Documents.
- Knowledge of GxP (Good Clinical/Manufacturing/Documentation practices)
- Knowledge of FDA Validation and CFR 21 Part 11
- Knowledge in Data Infrastructure/Security background is plus as well as any data Integrity & integration experience.

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