CSV and Data Integrity Manager

Description

Shape the Future of Pharmaceutical Manufacturing with Tata Chemicals Europe

Built on over 100 years of scientific expertise and driven by exceptional people, Tata Chemicals Europe is a business with a proud heritage and an exciting future.

Across our Cheshire sites, our colleagues are helping us deliver premium products, outstanding customer service, and a positive impact on our communities and environment. Now, we're entering an exciting new chapter.

Be Part of Something Ground-Breaking

We've launched Medi-Salt, the UK's first dedicated pharmaceutical-grade salt manufacturing facility. Producing high-purity salt for use as both an Active Pharmaceutical Ingredient (API) and pharmaceutical excipient, Medi-Salt is setting new standards in quality, compliance and innovation.

CSV and Data Integrity Manager opportunity has arisen

To support our continued growth and commitment to world-class quality, we're looking for a CSV and Data Integrity Manager to be the quality lead for digital, computerised and IT-enabled systems, ensuring that appropriate compliance, data integrity, computer systems validation, information security and audit readiness standards are embedded across the business.

The role provides independent quality oversight of computerised systems, data integrity, Computer Systems Validation and information security compliance, ensuring that appropriate methodologies, governance, quality risk management controls, metrics and escalation routes are in place.

Key Responsibilities

This is a highly visible role requiring someone who can work autonomously, influence across functions, manage audits and inspections confidently, and apply pragmatic, risk-based judgement while helping teams understand what good looks like without creating unnecessary complexity.

Key responsibilities include:

• Act as the Quality lead for eCompliance, data integrity, Computer Systems Validation and information security compliance across relevant systems and processes. Ensure appropriate methodologies, standards and procedures are developed, maintained and embedded within the Quality Management System.
• Provide Quality oversight throughout the computer-system lifecycle, including scoping, vendor selection, implementation, validation, go-live, routine operation, change control and periodic review. Ensure systems are compliant, robust, practical to operate and supported by appropriate lifecycle documentation.
• Ensure data integrity and information security principles are embedded into system design, implementation and operational use. Approve relevant data integrity methodologies, procedures, templates, assessments, remediation plans and change controls for key or critical systems.
• Review and approve key validation and project lifecycle documentation, including validation plans, GxP assessments, data migration plans, functional risk assessments, UAT/PQ test reports, validation reports, data migration reports and go/no-go decisions where appropriate.

Skills, Knowledge & Expertise

• Degree or equivalent in a scientific, technical, quality, compliance, IT, systems or business-related discipline, or equivalent practical experience overseeing computerised systems in a regulated or compliance-led environment.
• Experience in GxP, ERES, pharmaceutical, chemical, manufacturing, life sciences or another highly regulated environment.
• Experience of Computer Systems Validation, system lifecycle documentation, change control and periodic review in a regulated or compliance-led environment.
• Experience of managing or supporting regulatory inspections, customer audits or formal compliance audits. Strong understanding of data integrity expectations and how these apply to computerised systems and operational processes
• Experience of Computer Systems Validation, system lifecycle documentation, change control and periodic review.
• High level of technical ability, able to understand system architecture, access controls, data flows, back-up arrangements, resilience requirements and system-change implications.
• Strong stakeholder-management skills, with the confidence to influence across Quality, IT and operational teams.
• Strong written and verbal communication skills, including the ability to prepare audit material, policies, reports and senior-management updates.
• Pragmatic and solutions-focused, with the ability to balance compliance requirements with operational practicality.
• Formal training or qualification in auditing, validation, Quality Management, Computer Systems Validation, GxP, IT governance, data integrity or information security would be beneficial.
  
  

Job Benefits

Our people have always been at the centre of the company’s success and in return for their hard work and commitment, we offer a generous benefits package when engaged directly including:

• 37 days holidays per year, inclusive of Bank Holidays
• Roll over of up to 5 days and salary sacrifice holiday purchase scheme
• An additional paid day off each year to volunteer for a good cause in the local community
• 37.5 hours per week, Monday to Friday
• Excellent contributory Pension scheme up to 9% company contribution
• Life insurance
• Private Healthcare

Tata Chemicals Europe (TCE) is one of Europe's leading suppliers of sodium carbonate, salt and sodium bicarbonate and other products, from our plants in Cheshire, UK.

We are the UK's only manufacturer of sodium bicarbonate, the many grades of which have applications ranging from haemodialysis and pharmaceuticals, food and animal feed, flue gas treatments through to detergents and personal care products. Sodium carbonate (also known as soda ash) is primarily sourced from our US sister company, TCNA, and used in the manufacture of glass, detergents, chemicals and in several other industry applications.

Our British Salt Business is the UK's leading salt business, producing pure white salt for a variety of uses from food, water-softening, and industrial uses through to de-icing.

We have a long and proud history. Having been founded in 1874, and being a founder-member of ICI. Now owned by Tata Chemicals, we are proud to be part of the Tata Group of companies.

We work in conjunction with Morson Talent (www.morson.com) providing access to a small number of their recruiters to our Pinpoint recruitment system alongside our own in house team. Therefore, by submitting your application you understand that it may be dealt with by either the Tata Chemicals Europe or Morson dedicated team.

We reserve the right to close an advert early if we receive a high volume of suitable applications.