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Person Specification Title of Post: Validation Manager (Operational Excellence) Department : Validation Category Description Essentia l Desirabl e Assessment Method Skills & Abilities Proactive in ensuring you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements. Validation Management Interview Be committed to, and passionate about, providing a reliable and compliant service to meet and exceed the customer’s needs. Customer Interview The ability to influence and promote positive behaviours and performance through leadership. Validation Management Interview Ability to present publicly to senior management. Presentation 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. Presentation Capability to develop and manage a budget. Validation Management Interview A desire to actively mentor and develop members of the team, to willingly share your skills, knowledge and experience. Validation Management Interview Competent in the use of MS Office packages (i.e. Excel, PowerPoint, Visio, MS Project and Word) Validation Management Interview Advanced in the use of MS Office packages (i.e. Excel, PowerPoint, Visio, MS Project and Word) Validation Management Interview Knowledge & Experience Validation experience is not required; in fact, experience in departments other than Validation is preferred CV (pre- interview) Significant experience within a CV 1/ 2

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Person Specification

Title of Post: Validation Manager (Operational Excellence)

Department: Validation

Category Description Essential Desirable Assessment Method

Skills &Abilities

Proactive in ensuring you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.

Validation

Management Interview

Be committed to, and passionate about, providing a reliable and compliant service to meet and exceed the customer’s needs.

Customer Interview

The ability to influence and promote positive behaviours and performance through leadership.

Validation Management

Interview

Ability to present publicly to senior management. Presentation

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.

Presentation

Capability to develop and manage a budget. Validation

Management Interview

A desire to actively mentor and develop members of the team, to willingly share your skills, knowledge and experience.

Validation

Management Interview

Competent in the use of MS Office packages (i.e. Excel, PowerPoint, Visio, MS Project and Word)

Validation Management

Interview

Advanced in the use of MS Office packages (i.e. Excel, PowerPoint, Visio, MS Project and Word)

Validation Management

Interview

Knowledge &

Experience

Validation experience is not required; in fact, experience in departments other than Validation is preferred

CV(pre-interview)

Significant experience within a parenteral (bio)pharmaceutical or blood products manufacturing environment (API and/or fill/finish).

CV(pre-interview)

Extensive experience of effectively deploying resources to meet dynamic and competing business priorities

Validation

Management Interview

Experience of effectively managing the performance (both good and bad) of your direct reports.

Validation

Management Interview

Experience of administering validation services with execution performed by the user group or other support function outside validation.

Validation

Management Interview

A good understanding of risk and science based tools and their practical application.

Validation Management

Interview

1/2

Person Specification

Category Description Essential Desirable Assessment Method

Training &Education

Degree level qualification, science or engineering discipline or equivalent. HR Confirmation

(pre-interview)

Recognised Management qualification HR Confirmation(pre-interview)

Lean six sigma Green Belt qualification with significant practical experience of deploying lean tools in real life scenarios.

HR Confirmation(pre-interview)

Other Requirement

Able to attend BPL site to perform the role. HR Interview

Able to work outside of core hours when required to meet business needs. HR Interview

Capable of entering classified manufacturing areas. HR Interview

Able to travel within the UK and overseas, as required, to support business needs. HR Interview