Validation Officer - Cambridge, United Kingdom - Mundipharma

Mundipharma
Mundipharma
Verified Company
Cambridge, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

Provide Validation coordination and Executes validation projects, ensuring these are completed in line with GMP requirements, industry standards, company procedures and business requirements, collaborating with key stakeholders for the design, preparation, completion and final reporting.


  • Coordinate and executes, with limited supervision, assigned standard validation projects ensuring compliant and timely performance, in line with GMP requirements, industry standards (e.g., GAMP5), Regulatory Guidelines (e.g.

FDA Guidance for Industry, 'Process Validation:
General Principles and Practices), company procedures and business requirements, including the following activities:

  • definition in collaboration with key stakeholders of the validation strategy following a risk-based approach and ensuring regulatory and GMP requirements are met.
- preparation of Validation Plans and protocols in line with defined and approved validation strategy and company templates, coordinating the review and approval by the required stakeholders and issuance through the company's document management system.
- coordinate with limited supervision the overall validation program for a given project, including cleaning validation program
- management of validation nonconformances and resolution of issues with key stakeholders, including, Production, Engineering department and/or liaising with Quality Assurance and/or the Qualified Person as appropriate.
- coordination of the execution of Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV) and Cleaning Validation as defined in the respective validation plan/protocols, in close collaboration with Production and Quality Control departments.
- interpretation and reporting of validation analytical and process data, writing up of validation reports for each stage of the validation cycle, coordinating the review and approval by the required stakeholders and issuance through the company's document management system, ensuring documentation is completed and compliant with Data Integrity requirements.
- liaising with Quality Assurance to provide the necessary validation documentation to support batch certification by the Qualified Person for release to market.

  • Supports the business in managing the risk to quality by:
  • supporting change control activities, including performing validation impact assessments of changes, as required, including impact to the cleaning validation program.
- coordinate or supporting basic risk assessments using standard tools (e.g., FMEA) and the identification of risk control measures as appropriate;
- contributing to the definition of control strategy for existing equipment and/or processes, in close collaboration with the Production, Engineering and Quality Assurance.

Contributes to the company inspection readiness and compliance programs by:

  • completing on-time all assigned Quality System commitments (including Change Control actions, CAPA, training, document periodic reviews)
- supporting internal and external audits as required;

  • Ensures continuous professional development in order to stay up to date with current technology and validation regulatory standards and expectations.
  • Ensure Continuous Improvement of Validation processes, documentation and practices.

Primary Location:
GB Cambridge


Job Posting Date:

Job Type:

Permanent
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