Quality Validation Specialist

Idibu

Job Location:

Hatfield - UK

Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

Talentmark are recruiting for a Quality Validation Specialist to join a well-established and successful global pharmaceutical company based in Hatfield Hertfordshire for a 12 month fixed term contract.

Role:
You will be responsible for providing Quality oversight validation expertise and strategic support for the successful delivery of expansion projects. You will ensure that all qualification and validation activities associated with new facilities utilities warehouse operations and packaging lines are planned and executed in accordance with company procedures regulatory expectations and industry standards.

Key duties will be to:

Support the development and implementation of qualification and validation strategies for the company facility expansion project including the new coldchain warehouse packaging lines facility extensions and utility modifications.
Support the generation review and approval of project validation documentation including Qualification Plan URS Design Qualification Risk Assessments FAT/SAT protocols commissioning documentation IQ/OQ/PQ protocols validation reports and traceability matrices in line with company procedures and regulatory expectations.
Provide Quality oversight to ensure commissioning and qualification activities are executed in compliance with GMP GDP Annex 15 GAMP 5 and company requirements.
Coordinate with Engineering Production QC Supply Chain and other stakeholders to ensure equipment systems and facilities are introduced qualified and handed over in a controlled and compliant manner in accordance with the companys change management procedures.
Support and review validation activities for facility and utility systems such as HVAC compressed air environmental monitoring systems and temperaturecontrolled storage areas.
Provide Quality input to project design reviews equipment selection process flow development and risk assessments ensuring validation requirements are incorporated from early project stages.
Participate in investigations for deviations or nonconformances arising during commissioning and qualification ensuring appropriate root cause analysis corrective actions and preventive actions are defined.
Prepare and update SOPs and training materials associated with qualification validation and project delivery processes as required.
Support project teams with regulatory compliance guidance ensuring project documentation is inspectionready and aligned with cGxP expectations.
Identify and implement continuous improvement opportunities to enhance qualification and validation processes project delivery efficiency and compliance.
Provide training and coaching to project personnel and internal stakeholders on qualification validation and Data Integrity requirements.
Act as a strong advocate of Data Integrity ensuring documentation testing and record management associated with the projects comply with ALCOA principles.
Perform any appropriate duties at the request of the Quality Validation Manager.

Your Background:

Educated to degree level or above in a scientific or related field with significant experience in a pharmaceutical industry role focused on Electronic Quality Systems.
Proficient knowledge of electronic systems CSV and GAMP requirements and the ability to understand and analyse user requirements to facilitate changes and system improvements.
Working knowledge of facility and utility systems such as HVAC compressed air environmental monitoring systems
Good understanding of the requirements of data integrity and application to system management.
Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.
Good understanding of GMP Guidelines and Regulations.
Knowledge of the qualification and validation requirements for equipment and electronic systems.
Excellent verbal and written communication skills.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 186 008 in all correspondence.

Support the development and implementation of qualification and validation strategies for the company facility expansion project including the new coldchain warehouse packaging lines facility extensions and utility modifications.
Support the generation review and approval of project validation documentation including Qualification Plan URS Design Qualification Risk Assessments FAT/SAT protocols commissioning documentation IQ/OQ/PQ protocols validation reports and traceability matrices in line with company procedures and regulatory expectations.
Provide Quality oversight to ensure commissioning and qualification activities are executed in compliance with GMP GDP Annex 15 GAMP 5 and company requirements.
Coordinate with Engineering Production QC Supply Chain and other stakeholders to ensure equipment systems and facilities are introduced qualified and handed over in a controlled and compliant manner in accordance with the companys change management procedures.
Support and review validation activities for facility and utility systems such as HVAC compressed air environmental monitoring systems and temperaturecontrolled storage areas.
Provide Quality input to project design reviews equipment selection process flow development and risk assessments ensuring validation requirements are incorporated from early project stages.
Participate in investigations for deviations or nonconformances arising during commissioning and qualification ensuring appropriate root cause analysis corrective actions and preventive actions are defined.
Prepare and update SOPs and training materials associated with qualification validation and project delivery processes as required.
Support project teams with regulatory compliance guidance ensuring project documentation is inspectionready and aligned with cGxP expectations.
Identify and implement continuous improvement opportunities to enhance qualification and validation processes project delivery efficiency and compliance.
Provide training and coaching to project personnel and internal stakeholders on qualification validation and Data Integrity requirements.
Act as a strong advocate of Data Integrity ensuring documentation testing and record management associated with the projects comply with ALCOA principles.
Perform any appropriate duties at the request of the Quality Validation Manager.

Your Background:

Educated to degree level or above in a scientific or related field with significant experience in a pharmaceutical industry role focused on Electronic Quality Systems.
Proficient knowledge of electronic systems CSV and GAMP requirements and the ability to understand and analyse user requirements to facilitate changes and system improvements.
Working knowledge of facility and utility systems such as HVAC compressed air environmental monitoring systems
Good understanding of the requirements of data integrity and application to system management.
Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.
Good understanding of GMP Guidelines and Regulations.
Knowledge of the qualification and validation requirements for equipment and electronic systems.
Excellent verbal and written communication skills.

Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 186 008 in all correspondence.

Apply Now

About Company

Idibu

100 employees

Every business is now operating in an environment that’s susceptible to change. idibu has evolved against this changing backdrop. Whether driven by legislation, technology, customer demand or the economy, businesses now need to be agile and fleet of foot to ensure they can attr ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click