Pharmacy Production Technician

MAC Clinical Research; Manchester; On-site; GBP 32,000 - 42,000; Full time

Benefits offered by this job

Health Insurance

Eye Care Vouchers

Free onsite parking

25 days annual leave (increasing to 30

Your birthday off work

Job summary

MAC Clinical Research in Manchester is seeking a Pharmacy Production Technician to join our dedicated team. You will produce sterile and non-sterile Investigational Medicinal Products, comparators or nIMP, and support subject dosing in collaboration with the Production Manager.

You will oversee day-to-day dosing operations, ensure proper staffing, manage consumables, and participate in training and GMP-compliant documentation, with exposure to audits and regulatory inspections.

Qualifications

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

Responsibilities

• Work with the Pharmacy Production Manager to ensure subject dosing is completed and sent to the appropriate sites in a timely manner.
• Ensure that subject dosing is planned around the Production Team schedule.
• Ensure adequate staffing available for dosing along with other day to day duties.
• Involved in preparing doses (sterile / non-sterile).
• Supervise and organise day to day workload of the Production Team and delegate tasks as appropriate.
• Ensure we have the appropriate number of consumables and goods to operate on a daily basis and 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.
• Ensure production documentation is completed to ensure complete accountability of study material and investigate discrepancies.
• Ensure that appropriate storage conditions are maintained for Investigational Medicinal Product / commercial and comparator.
• 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.
• Assist with internal audits, self-inspections, and regulatory inspections as required.
• Assist with production documentation; un-blinded and blinded dispensing/assembly or manufacture of medication/IMP/nIMP and supply/resupply.
• Ensure all processes and procedures are GMP compliant.
• Raise quality events in a timely manner.
• Help generate and update GMP SOPs when necessary.
• Deputise in the absence of the Production Manager / Assistant Production Manager.
• Complete broth validations and end of session media fills as per schedule.
• Perform all aspects of validations, performance qualifications and study dry runs.

Skills

GMP manufacturing

Validation

Investigations

Job 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 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.