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Life Science - SME / Validation / Quality - Surrey

  • Location

    Guildford, Surrey

  • Sector:

    Life Sciences

  • Job type:

    Temporary

  • Salary:

    £40 - £41 per hour + limited

  • Contact:

    Mark Pritty

  • Contact email:

    Mark.Pritty@talascendint.com

  • Job ref:

    BBBH92822_1625156980

  • Published:

    about 1 month ago

  • Duration:

    6 Months +

  • Expiry date:

    2021-07-31

  • Startdate:

    ASAP

  • Consultant:

    #



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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-

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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) *