You have successfully logged out!
Menu
Jobs found
saved
add to favourites
Search News
Search Videos

QA, Biologics, Manager

Berkshire, United Kingdom

  • Salary: Dependent on experience
  • Job type: Interim/Contract
  • Posted: 18/10/2018
  • Contact name: Frankie Cunningham
  • Contact number: 01892 612612
  • Ref: 3693

Job description

This position will support operational Quality Assurance activities for our client’s biological development projects. This will be achieved through close partnering with QA inhouse and vendor sites, and collaboration with Technical Operations and other inhouse teams. 

The Role:
Provide advice and support on operational and general QA activities to teams working on Drug Substance (DS) and Drug Product (DP) development, Technology transfer, manufacture and submission preparation. In particular :

- Review and approval of project documentation, for example:

  • Technology Transfer protocols and Reports
  • Manufacture and analytical testing (process description, master batch records, analytical methods, specifications)
  • Quality Agreements
  • Process development studies (including holding times, filter validation, impurities clearance, extractable/leachable, material of contact, shipping qualification, validation summary reports)
  • Analytical validation studies according to ICH Q2
  • Stability studies
  • Protein characterisation
  • Mammalian working cell banks (preparation, testing, characterization)
  • Review of completed CMO batch documentation
  • Deviations, Change controls, CAPA

Such review will include :

  • Check of referenced documents and data
  • Compliance with relevant protocol, SOP or GMP guideline
  • Compliance with regulatory guidelines
  • Deviations and changes are properly addressed and documented
  • Consistency with other documents
  • Discussions and conclusions are pertinent and consistent with data
  • Comments from review are correctly addressed

- Review and approve analytical, DS and DP CMC submission sections
Such review will include :

  • Consistency with supportive documents
  • Consistency with other sections
  • Comments from review are correctly addressed
  • Content is in line with relevant regulatory guideline

Work closely with Technical Operations teams to ensure that all QA services for the project are provided in an effective and efficient way.

Required Experience:

Experience:

  • Minimum of 5 years working in the pharmaceutical biologics industry in a quality assurance position. Operational GMP experience would be a distinct advantage.
  • Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations together with quality principles and techniques.
  • Experienced in one or more of the following:
    - regulatory submission preparation for biological products
    - ICH Q2 analytical method validation principles and general analytical techniques
    - GMP process validation
    - DS and/or DP process manufacture for biological products

Specific skills:

  • Demonstrates initiative and an ability to help team and others solve problems creatively
  • Ensures free flow of information to the appropriate stakeholders
  • In-depth knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques
  • Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the business
  • Understands practical applications of GMP, compliance principles and theories incl. risk management

Problem solving:

  • Identifies risks and proposes corrective actions in complex situations
  • Applies appropriate strategies and option based rationale
  • Applies best practices, principles and theories in moderately complex situations and issues
  • Gives input based on expertise and awareness of business implications
  • Demonstrates initiative and an ability to help team and others solve problems creatively and practically Implements risk based approach
  • Takes innovative approach to working practices

If this role is of interest please make an application by either completing the form below or contacting me directly on 01892 612 612 or frankie.cunningham@hobsonprior.com