MAC Clinical Research - Pharmacy Production Technician

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.
• Assisting in client monitoring visits.
• 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.