Life Science - SME / Validation / Quality -

Accountabilities * Related performance indicators +

To generate/ review risk assessments, periodic reviews,	Positive feedback from
investigations, and any other Quality Assurance	stakeholders and
documentation as appropriated related to product	colleagues.
Reintroduction.	Project tasks are performed
	on time.
To assist in maintenance of QA systems including	Positive feedback from
deviation handling, CAPA, investigations, change	stakeholders and
control, document control, internal audits, etc	colleagues.
supporting production areas to successfully deliver	Project tasks are performed
activities agreed within QA.	on time.
Providing day-to-day oversight of project tasks status,	Positive feedback from
dealing with technical, planning and compliance issues	stakeholders and
and providing QA support for other project team members	colleagues.
and key stakeholders to ensure the business has the	Project tasks are performed
required QA support.	on time.

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Regulatory and / or Organisational Requirements*
Ensure compliance with BI Corporate and local procedures and policies, and external GxP and Biosafety Regulations.

Job Complexity*

The right candidate must be able to interpret and implement quality pharmaceutical standards and provide accurate and comprehensive feedback to colleagues.

Must have a good understanding of FDA, EudraLex, ISPE, OMG regulations and guidelines for QA activities in the pharmaceutical industry; to deliver all the QA tasks related to a project for product reintroduction.

Able to work as part of a project team with a commitment for supporting other colleagues.
Interfaces*
Meet with stakeholders, process owners (Quality Control, Production, technical Team) to understand both QA and validation input and needs.

Job Expertise*

Excellent knowledge of MS Office and PowerPoint packages.
Excellent written and verbal communication skills alongside experience authoring technical documentation.
A good understanding of current Good Manufacturing Practices (GMPs) & Data Integrity. A good understanding of validation principles and practices in the risk-based approach.
A good understanding of validation activities in the pharmaceutical industry (Process, cleaning, equipment).
Demonstrate ability to work collaboratively across functions.
Comprehensive appreciation of Pharmaceutical Quality Systems (Deviations, CAPA, Internal Audits, Change Control, Documentation management, etc)

Job Impact*

Expand Pirbright product portfolio. Contributes to attain aggressive timelines related to BTV reintroduction project at the Site.
Support maintaining/generating Quality Compliance for the Pirbright Site.

Must have experience for minimum 3 years in both process validation and in cleaning validation following current GMP standards.
Comprehensive appreciation of pharmaceutical quality systems.
Be self-sufficient and effectively work with limited supervision.
Proactive Person, able to recognize potential problems and successfully managing solutions.
Possess an agile mind and ability to change priorities and adapt outputs to changing business needs.
Excellent communication skills, able to articulate complex information with internal customers and supporting functions such as QC, QA, Engineering, Technical, understanding their concepts and concerns.
Good networking skills.

Minimum Education/Degree Requirements*
Bachelor's degrees in a relevant science or

Required Capabilities (Skills, Experience, Competencies) *