Quality Validation Manager

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Job Details

Location
Glasgow, Scotland Hybrid North East
Salary
£45,000 - £57,000 per annum- dependent on experience
Employment
Full-time - Permanent
Team
Quality
Deadline
28 Jan 2022 - 23:30
Reference
CPI-3983-21
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About CPI

At CPI we work with our partners to translate inventions into products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries.

With a deep understanding of innovation processes and funding, outstanding technical expertise and industry relevant assets, we enable products and processes to be quickly and cost-effectively brought to market. This supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK.

Our partners operate across many diverse markets including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.

Hybrid Working

We’re embracing hybrid working to build a happier, more productive, and environmentally conscious workplace. Discover more about our new flexible working approach.

Read more

Why this role is important for CPI’s work

CPI has a new opportunity for a Quality Validation Manager. Who will also support GMP compliance for all CPI’s facilities including the National Biologics Manufacturing Centre (NBMC) — RNA Centre of Excellence and Medicines Manufacturing Innovation Centre (MMIC) Therefore this role will include travel to all CPI’s North East sites and Glasgow. With a primary focus on supporting CPI’s GMP facilities based at Darlington and Glasgow.

The role will support the GMP Operations team, IT/CSV and Quality team ‑including Data Integrity to ensure all validation activities comply with cGMP – specifically Annex 15. Also, to deliver GMP compliance and enable the attainment of GMP certificates and manufacturing authorisations and lead on all aspects of Validation during MHRP inspection and customer/​partner audits.

Reporting directly to the Quality Director the role holder will have the opportunity to build validation structure, policies and procedures. They will lead, develop and implement CPI’s Validation philosophy and its approach to GMP compliant Validation, across all aspects including Facility, Equipment, Process, Product, Analytical method, Cleaning and Computer systems. 

The role holder will develop CPI’s approach to GMP compliant validation. 

They will act as CPI’s subject matter expert in validation. To present CPI’s approach to validation to the MHRA

They will be an integral part of the Quality Management team at CPI, working across CPI, with the Quality Managers for each of the Business Units. Supporting the delivery of the quality objectives identified within the quality roadmap. Working with associates to ensure compliant practices are implemented in all GMP facilities.

Read about CPI’s new facilities by clicking on the links below:

RNA Centre of Excellence — Darlington

Medicines Manufacturing Innovation Centre — Glasgow 

The Role:

Develop and implement CPI’s validation philosophy and approach.

Develop and implement the Validation Policy, validation framework and holistic Validation Master Plan (VMP) across CPI 

Develop and implement CPI’s validation standards and standard operating procedures.

Generate and maintain the CPI VMP to ensure all facility, equipment, process, utilities, analytical methods, cleaning and computerised systems are qualified in compliance with regulations and standards, and specifically with GMP.

Work with the Business Units (BUs), Grand Challenge (GC) teams and Quality Validation Specialists, adopting a risk management approach, to define the overall validation strategy for each of the BUs / GCs. 

Liaise with external stakeholders, including the MHRA, to ensure the validation philosophy and strategy towards innovative concepts, GCs and new facility projects are viable within cGMP regulations and guidelines.

Provide the framework and appropriate templates to support the generation of the URS, DQ, IQ, OQ and PQ documentation.

Work with the Business Units/​Grand Challenge teams to determine the overall Validation strategy for the implementation of the Development Work Packages and new project work packages so that the required compliance to GMP is planned and enabled during GC / project definition and equipment/​facility specification and then carried forwards through procurement, installation, commissioning and into operations.

The person we are seeking

It is essential you are qualified to a minimum of degree level in a Science or Engineering discipline

You must have significant and demonstrable experience in a GMP environment/​GMP certified facility, preferably in an Operations or Quality Validation role

Is essential that you also have significant and relevant Validation experience, with demonstrable previous experience in presenting to the MHRA

Demonstratable experience in the successful validation of GMP equipment/​facility/​process, writing validation master plans, protocols and reports is also essential.

What does CPI offer you?

At CPI, we offer a wide range of benefits to our employees, this includes:

  • Up to 36 days holiday, including bank holidays – Plus a holiday purchasing scheme
  • Generous pension scheme
  • Life assurance and accident insurance schemes
  • Flexible working
  • Learning and Development Opportunities
  • Free parking

Find out more about our culture and benefits.

Additional information

CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.

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