• GREATER MANCHESTER Early Phase - FULL TIME

SENIOR PHARMACY TECHNICIAN

Closing date for applications: 31 August 2021


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 Senior Pharmacy Technician 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 Manchester, with travel to other sites as required.


The purpose of this role is to produce Aseptic, Sterile and Non-sterile Investigational Medicinal Products, comparators or nIMP.


KEY RESPONSIBILITIES:

  • Ensure compliance of the manufacturing unit with EU GMP

  • Ensure that all processes and procedures are GMP compliant.

  • Ensure that study production documentation is completed to ensure complete accountability of study material.

  • Ensure that appropriate measures are taken that Investigational Medicinal Product / commercial and comparator products are kept at the appropriate storage conditions.

  • Investigate and report any excursions regarding storage of study drug material.

  • Maintain documentation of storage conditions

  • Contribute to departmental service review and performance monitoring.

  • Assist with internal and external audits, self- inspections, monitoring visits 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 quality events are raised in a timely manner.

  • Ensure timely corrective actions are taken in the event of an adverse monitoring report

  • Assist with the generation and update of GMP SOP’s when necessary.

  • Provide support and guidance to the production assistants.

  • 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.

  • Ensure any medication to be used as a comparator or nIMP is ordered and received in a timely manner.

  • Ensure all quarterly broth validations and weekly end of session media fills are completed.

  • Perform all aspects of validations, performance qualifications and study dry runs.

  • Assist with review and update of SOPs to ensure unit runs to compliance and efficiently.

KEY REQUIREMENTS:

  • Experience working in aseptic environment

  • Experience working in sterile environment

  • Good knowledge of Good Manufacturing Practice

  • Good knowledge of Good Clinical Practice

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 - Senior Pharmacy Production Technician
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Salary: Competitive + Negotiable £ Apply Now

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