Pharmacy Production Assistant

3 days ago

Leeds, United Kingdom MAC Clinical Research Full time

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

We are looking for an enthusiastic individual who is capable of working with our friendly and ever-expanding team.

It’s essential that you have experience within production/manufacturing setting in a production role that requires accurate, completion of manufacturing documentation.

**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.

**KEY REQUIREMENTS**:

- Good basic general education.
- Numeracy skills required.
- Ability to follow written and verbal instructions.
- Ability to communicate effectively.
- Good team working skills
- Computer literate
- Receptive to change
- Ability to prioritise workload and meet deadlines

**DESIRABLE REQUIREMENTS**:

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

**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)

**Job Types**: Full-time, Permanent

**Benefits**:

- Company pension
- Free parking
- On-site parking
- Private medical insurance

Schedule:

- 8 hour shift
- Monday to Friday

Work authorisation:

- United Kingdom (preferred)

Work Location: One location

Reference ID: HR138

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