• WEST YORKSHIRE - FULL TIME

PRODUCTION ASSISTANT

Closing date for applications: 27 May 2022

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 are seeking to appoint a Production Assistant to join our Pharmacy team and make a positive impact in a growing and progressive CRO. You will be joining a company that put the needs and wellbeing of their people first, who are inclusive and who deliver exceptional service – together.


This role is full time and based at Leeds, West Yorkshire site, with travel to other sites as required.


The purpose of this role is to Produce sterile and non-sterile Investigational Medicinal Products, comparators or nIMP.


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; un-blinded 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.

KEY REQUIREMENTS:

  • Experience in GMP manufacturing, Validation and investigations for Global and Contract Pharmaceutical manufacturing organisations.

BENEFITS:

  • Competitive salary in keeping with pharmaceutical industry standards and will reflect experience

  • Free onsite parking at MAC office locations

  • Health Insurance

  • 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years service)

  • Your birthday off work

  • Regular hours (including Christmas Day, Boxing Day and New Years Day off)


MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential.

You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.


Please note that if we receive a high volume of applications this date may be brought forwards.


Job Description - Production Assistant
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