Senior Production Specialist - sterile manufacturing

Job Ref: J30989
Sector: Science
Sub-sectors: Pharmaceuticals, Medical Devices
Job Type: Temporary
Date Added: 09 March 2019
  • Hurley, Berkshire, England, UK Honey Lane Hurley Berkshire UK SL6 6RJ
  • £21.99 - £28.59 per Hour
    HOUR
  • Tolu Kuforiji
  • 01618682248
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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Job Title: Senior Production Specialist - sterile manufacturing

Location: Berkshire (near Maidenhead)

Contract: 6 Months initially

Pay Rate: up to £55,000 per annum

SRG is working with a biopharmaceutical company who are global leaders in their field.

They are currently seeking a Senior Production Specialist to act as a Subject Matter Expert (SME) in the area of sterile manufacturing for their virtual manufacturing site near Maidenhead.

Though an initial 6-month contract the intention is for this new role to be ongoing.

Responsibilities:

  • Act as Subject Matter Expert for production processes supporting QPs and relevant departments.
  • Provide technical expertise in issue resolution for aseptically manufactured and terminally sterilised products such as deviation impact assessment, assembly, cleaning, batch review and compliance to module 3 regulatory dossiers.
  • Oversee Batch Release On-boarding programme providing training in sterile manufacturing related matters.
  • Support Quality Assurance (Batch Release) to ensure quality systems are operating effectively.
  • Liaise with manufacturing sites and contract manufacturing organisations (CMOs) as part of the batch release process.

Requirements:

  • Extensive experience of working in a sterile production environment to GxP standards, experience of multi-dose production is ideal.
  • Frontline exposure of auditing for MHRA/EMEA inspections (FDA experience would be advantageous).
  • Good understanding of analytical techniques used in quality control units.
  • Ability to lead complex investigations through to root cause and provide appropriate CAPA.

Applications are expected to be reviewed early next week (from 11th March) so apply online today! For more information on the role contact Tolu Kuforiji on 0161 868 2248.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
08/04/2019 15:21:40
GBP 21.99 21.99