Pharmacy Production Assistant

MAC Clinical Research has an exciting vacancy available for a Pharmacy Production Assistant in our Leeds, West Yorkshire clinic, producing sterile and non-sterile Investigational Medicinal Products, comparators or nIMP.

We are looking for an enthusiastic individual who can work with our friendly and ever-expanding team.

KEY REQUIREMENTS:

• Good basic general education.
• Numeracy skills required.
• Ability to follow written and verbal instructions.
• Ability to communicate effectively.
• Good team working skills
• Previous experience within a manufacturing/production setting that requires the accurate completion of production documentation

DESIRABLE REQUIREMENTS:

• Experience in GMP, GLP, GCP, GDP or GxP industries

KEY RESPONSIBILITIES:

• Assist with dispensing, assembly & manufacturing of investigational medication. Including aseptically prepared injection, tablets, capsules, and suspensions
• Assist with internal audits, self- inspections, and regulatory inspections as required.
• 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.
• Assisting client monitoring visits.
• Help generate and update GMP SOP’s when necessary.
• Report and take direction from management 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 is ordered and received in a timely manner before the start of the study.
• 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.
• Assist in validation of 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.
• Ensure unit cleanliness is maintained, using environmental cleaning agents supplied.
• Identify areas for improvement.
• Identify potential training needs and request support from the Production Manager and Technician
• Identify priorities; bring issues to the attention of colleagues for the smooth running of the Production Unit.

• 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

Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.