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 opportunity for a Pharmacy Production Technician to join our dedicated team in Manchester.
FOCUS OF THE JOB:
- Produce sterile and non-sterile Investigational Medicinal Products, comparators or nIMP.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
- Experience in GMP manufacturing, Validation and investigations for Global and Contract Pharmaceutical manufacturing organisations is essential.
RESPONSIBILITIES:
- Working with the Pharmacy Production Manager to ensure subject dosing is completed and sent to the appropriate sites in a timely manner.
- Ensuring that subject dosing is planned around the Production Team schedule.
- Ensuring adequate staffing available for dosing along with other day to day duties
- Involved in preparing doses (sterile / non-sterile)
- Supervising and organising day to day workload of the Production Team and delegate tasks as appropriate
- Ensuring we have the appropriate number of consumables, goods to operate on a daily basis and to initiate ordering when necessary.
- Ensure that cleaning, environmental monitoring and routine tasks are completed on time and to procedure.
- Participate and lead in the training of staff.
- To ensure that production documentation is completed to ensure complete accountability of study material and investigate discrepancies.
- To ensure that appropriate measures are taken so that Investigational Medicinal Product / commercial and comparator are kept at the appropriate storage conditions.
- To maintain documentation of storage conditions and resolve production issues.
- Investigate and report any excursions regarding storage of study drug material and contact the sponsor.
- Contribute to service review and performance monitoring.
- To assist with internal audits, self- inspections, and regulatory inspections as required.
- Assisting with production documentation; un-blinded and blinded dispensing/assembly or manufacture of medication/IMP/nIMP and supply/resupply.
- To ensure that all processes and procedures are GMP compliant.
- Ensure quality events are raised in a timely manner.
- Help generate and update GMP SOP’s when necessary.
- To deputise in the absence of the Production Manager / Assistant Production Manager.
- To complete broth validations and end of session media fills as per schedule.
- To perform all aspects of validations, performance qualifications and study dry runs.
BENEFITS:
- Health Insurance
- Eye Care Vouchers
- 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 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.
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