Validation Manager
- Recruiter
- Confidential
- Location
- Dublin
- Salary
- Competitive
- Posted
- 19 Oct 2021
- Closes
- 16 Nov 2021
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Permanent
- Hours
- Full Time
Why work for this company?
Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.
Company Profile
65+ years of experience in animal health.
Nearly $6 billion annual revenues.
25 manufacturing sites around the world.
10,000 employees worldwide of which 1,100 employees are committed to R&D. The primary purpose of this role will be to lead and manage the Validation functions ensuring all validation activities within the site are in compliance with cGMP guidelines and company Validation Policy
This role will be key in the oversight and management of the site Validation Master Plan and ensuring full adherence to project timelines, and including IQ, OP, PQ and effective installation.
Responsibilities
Lead and manage the Validation activities within the site including but not limited to thermal validation, irradiation validation, equipment validation, facility validation and process validation.
Implement and continually improve the validation system in line with appropriate national, European and international good practice standards and the strategic objectives of the site.
Combine the day to day management of the Validation department with a hands-on approach to functional tasks.
Develop and promote a programme of activities that create and sustain a culture of quality and ensure an ongoing focus on the efficiency and continued appropriateness of procedures.
Investigation and review of OOS validation results. Reporting of all investigations in line with appropriate procedures.
Advising as part of the site management team on Validation issues.
Lead and manage the validation function through the effective provision of well-defined goals and objectives, leadership training, support and guidance, and performance management to ensure consistent sustainable performance.
Build and utilise effective cross-functional relationships with key stakeholders including Manufacturing and Quality Assurance.
Execution of Validation Studies, developing protocols for execution, coordination of validation studies and reporting of results in an effective and timely manner.
Preparation and execution of Risk Assessment studies as required (e.g. for change proposals and deviations). ??? Planning, coordination and execution of the site shutdown program with regards to Validation activities. ??? Develop systems to monitor the effectiveness of the validation system and issue relevant reports to measure and monitor performance.
Be accountable for the effective management of Technical Service Agreements for Critical Plant Systems - HVAC, Water Systems (DI, RO, WFI), Pure Steam, Autoclaves, Compressed Air.
Develop and manage the validation budget, ensuring expenditure is in line with agreed objectives and within agreed budget levels.
Develop and manage the budget for capital projects as necessary. Requirements
Minimum 3 years' experience working in a validation environment.
Knowledge of respective standards and good manufacturing practices.
Excellent interpersonal and communication skills. ??? Critical thinking and evaluation of process problems.
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.
Company Profile
65+ years of experience in animal health.
Nearly $6 billion annual revenues.
25 manufacturing sites around the world.
10,000 employees worldwide of which 1,100 employees are committed to R&D. The primary purpose of this role will be to lead and manage the Validation functions ensuring all validation activities within the site are in compliance with cGMP guidelines and company Validation Policy
This role will be key in the oversight and management of the site Validation Master Plan and ensuring full adherence to project timelines, and including IQ, OP, PQ and effective installation.
Responsibilities
Lead and manage the Validation activities within the site including but not limited to thermal validation, irradiation validation, equipment validation, facility validation and process validation.
Implement and continually improve the validation system in line with appropriate national, European and international good practice standards and the strategic objectives of the site.
Combine the day to day management of the Validation department with a hands-on approach to functional tasks.
Develop and promote a programme of activities that create and sustain a culture of quality and ensure an ongoing focus on the efficiency and continued appropriateness of procedures.
Investigation and review of OOS validation results. Reporting of all investigations in line with appropriate procedures.
Advising as part of the site management team on Validation issues.
Lead and manage the validation function through the effective provision of well-defined goals and objectives, leadership training, support and guidance, and performance management to ensure consistent sustainable performance.
Build and utilise effective cross-functional relationships with key stakeholders including Manufacturing and Quality Assurance.
Execution of Validation Studies, developing protocols for execution, coordination of validation studies and reporting of results in an effective and timely manner.
Preparation and execution of Risk Assessment studies as required (e.g. for change proposals and deviations). ??? Planning, coordination and execution of the site shutdown program with regards to Validation activities. ??? Develop systems to monitor the effectiveness of the validation system and issue relevant reports to measure and monitor performance.
Be accountable for the effective management of Technical Service Agreements for Critical Plant Systems - HVAC, Water Systems (DI, RO, WFI), Pure Steam, Autoclaves, Compressed Air.
Develop and manage the validation budget, ensuring expenditure is in line with agreed objectives and within agreed budget levels.
Develop and manage the budget for capital projects as necessary. Requirements
Minimum 3 years' experience working in a validation environment.
Knowledge of respective standards and good manufacturing practices.
Excellent interpersonal and communication skills. ??? Critical thinking and evaluation of process problems.
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003