Validation Manager - BPL Recruitment


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Jobs: Engineering

Validation Manager

Department
Engineering
Job Type
Permanent
Posted
05/02/2019
Closing
01/05/2019
Salary Grade
65000
Job Band
C

Details

BPL require an experienced Validation Manager to join our business critical team here at our head office in Elstree

Vacancy Overview

Implementation of the required processes relating to commissioning, qualification and validation within the remit of your role. Ensuring compliance with all applicable (EHS and GxP) regulatory and internal standards and industry best practices. Organise and deploy resources effectively to deliver validation services to meet and exceed customer expectation. Be committed to, and passionate about, providing a reliable and compliant service to meet and exceed the customer's needs.

Duties and Responsibilities 

  • Ensure personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
  • Responsibility for the compliance of all assets at the Elstree facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
  • Maintain an ongoing dialogue with Validation Management to ensure resources are effectively deployed to meet dynamic and competing business priorities.
  • Delivery of implementation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
  • Ensure that risks to product quality, patient safety and/or data integrity throughout the validation lifecycle are understood, transparent and managed through the application of a quality risk management approach.
  • Identify skills and competency development needs within the team. Support individual and team development through the Elstree training processes.
  • Actively participate in the identification, recruitment and on-boarding of resource (staff and contract) into the organisation.
  • Proactively manage the performance of the personnel operating under your remit.
  • Continuously improve validation processes to eliminate waste, improve effectiveness and efficiency, whilst in alignment with industry best practices and stakeholder requirements.
  • Oversight of commissioning, qualification and validation implementation within your remit and, in conjunction with your peer group, across the validation team to ensure consistent service delivery and systemic application of process improvements.
  • Directly assist the Head of Validation in ensuring that adequate budget (opex and capex) is planned and spent in support of the validation team.
  • Integrate with, and interact across, all relevant functions including Engineering, Quality Assurance, Manufacturing and/or Supply Chain to ensure compliant validation service delivery to the assets across the site.
  • Escalation to the Head of Validation, at the earliest opportunity, when issues or obstacles that impact compliance or on time delivery.

All other tasks and duties, as necessary, to maintain the effectiveness of the validation service as required by the business and/or Head of Validation.

Experience

Educated to Degree level qualification, science or engineering discipline or equivalent.

Skills and Experience

  • o A good understanding of risk and science based tools and their practical application in driving execution strategies.
  • o Communication (including the ability to understand, summarise and communicate complex issues) be it by phone, email, teleconference, face to face or presenting is a key skill for this role.
  • o Significant recent leadership and management experience. The ability to influence and promote positive behaviours and performance through leadership.

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