Gmp Production Assistant - Leeds, United Kingdom - MAC Clinical Research

MAC Clinical Research
MAC Clinical Research
Verified Company
Leeds, United Kingdom

1 week ago

Tom O´Connor

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Tom O´Connor

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Description
MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.


We have an exciting vacancy available for a Pharmacy Production Assistant in our Leeds, West Yorkshire Pharmacy team, producing sterile and non-sterile Investigational Medicinal Products, comparators or nIMP.


  • Do you want to learn new skills that you will not learn anywhere else? _
  • Are you looking for a role where you can really make a difference? _
  • Do you have an interest in Pharmacy and Research? _
If your answer's yes, then we want to hear from you


Key requirements:


  • Your CV will need to show experience in GMP manufacturing and/or a real interest in drug development
  • Good exam results from school or recent BSc graduate
  • Positive, motivated and hard worker

Key Responsibilities

  • Ensure that study production documentation is completed to ensure complete accountability of study material and investigate discrepancies.
  • Ensure that appropriate measures are taken that Investigational Medicinal Product / commercial and comparator are kept at the appropriate storage conditions.
  • Contribute to service review and performance monitoring.
  • Assist with internal audits, self
- inspections and regulatory inspections as required.

  • Assist with production procedures; unblinded and blinded dispensing/assembly or manufacture of medication/IMP/nIMP and supply/resupply.
  • Ensure that all processes and procedures are GMP compliant.
  • Maintain documentation of storage conditions and resolve production issues.
  • Ensure quality events are raised in a timely manner.
  • Investigate and report any excursions regarding storage of study drug material.
  • Assisting client monitoring visits.
  • Help generate and update GMP SOP's when necessary.
  • Support and guide the Production Technician.
  • Report and take direction from management to ensure service levels are maintained and the unit functions appropriately and safety.
  • Ensure all consumables for example bottles, syringes, needles etc are ordered and received in a timely manner before the start of a study.
  • Ensure any medication to be used as a comparator or NIMP is ordered and received in a timely manner before the start of the study.
  • Complete broth validations and end of session media fills.
  • Perform all aspects of validations, performance qualifications and study dry runs.
  • Assist in ordering and maintenance of clinical equipment for studies as and when required.
  • Validate any new equipment that is required for Production.
  • Maintain all environmental standards required for the Production unit as defined in standards laid out by GMP. To ensure timely corrective actions are taken in the event of an adverse monitoring report.
  • Ensure unit cleanliness is maintained, using environmental cleaning agents supplied.
  • Identify areas for improvement.
  • Identify potential training needs and request support from the Production Manager and Technician
  • Identify priorities; bring issues to the attention of colleagues for the smooth running of the Production Unit.

BENEFITS:


  • Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
  • Health Insurance
  • Free onsite parking
  • 25 days annual leave (increasing in increments to 30 days after 6 years' service)
  • Your birthday off work

Benefits:


  • Company pension
  • Free parking
  • Onsite parking
  • Private medical insurance

Schedule:

  • 8 hour shift

Work authorisation:

  • United Kingdom (required)

Work Location:
In person


Reference ID:
HR282
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