Closing date for applications: 31 May 2021
MAC Clinical Research manages clinical trials for the pharmaceutical industry and an exciting range of career opportunities exists in our expanding Clinical Research Organisation.
We are seeking to appoint a Production Assistant to join our dedicated Pharmacy Team in Leeds.
The focus of this role is to provide to produce sterile and non-sterile Investigational Medicinal Products, comparators or nIMP.
Excellent communication skills and the ability to work within a team are essential and full training will be given on the role.
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.
Assist in client monitoring visits.
Help generate and update GMP SOP’s when necessary.
Support and guide the Production Technician.
Report and take direction from the Production Manager 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 and ensure timely corrective actions are taken in the event of an adverse monitoring report.
Ensure unit cleanliness is maintained, using environmental cleaning agents supplied.
Participate in monthly GMP meetings, when required by the Production Manager
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
Experience in GMP manufacturing, Validation and investigations for Global and Contract Pharmaceutical manufacturing organisations.
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave (increasing in increments to 30 days after 6 years service)
Your birthday off work
MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil 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.
Salary: Competitive + Negotiable £ Apply Now