Clinical Production Assistant

4 weeks ago

Manchester, United Kingdom MAC Clinical Research Full time

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 Production Assistant to join our 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 based at Manchester, with business travel as required.

The focus of this role is to 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.

**RESPONSIBILITIES**:

- To ensure that study production documentation is completed to ensure complete accountability of study material and investigate discrepancies.
- To ensure that appropriate measures are taken that Investigational Medicinal Product / commercial and comparator are kept at the appropriate storage conditions.
- Contribute to service review and performance monitoring.
- To assist with internal audits, self
- inspections and regulatory inspections as required.
- Assisting with production procedures; 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.
- To 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 in client monitoring visits.
- Help generate and update GMP SOP’s when necessary.
- To support and guide the Production Technician.
- Report and take direction from the Production Manager to ensure service levels are maintained and the unit functions appropriately and safety.
- To ensure all consumables for example bottles, syringes, needles etc are ordered and received in a timely manner before the start of a study.
- To ensure any medication to be used as a comparator or nIMP is ordered and received in a timely manner before the start of the study.
- To complete broth validations and end of session media fills.
- To perform all aspects of validations, performance qualifications and study dry runs.
- To assist in ordering and maintenance of clinical equipment for studies as and when required.
- To validate any new equipment that is required for Production.
- To maintain all environmental standards required for the Production unit as defined in standards laid out by GMP. To ensure timely corrective actions are taken in the event of an adverse monitoring report.
- To 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
- Ensure training folder is updated and maintained.
- Ensure mandatory and necessary training for the role is completed.
- To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice
- To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business related data.
- To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out.

**BENEFITS**:

- Competitive salary in keeping with pharmaceutical industry standards and will reflect experience.
- 25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years long service)
- Private Health Insurance
- Your birthday off work

**Benefits**:

- Company pension
- Free parking
- On-site parking

Schedule:

- Monday to Friday
- Weekend availability

Ability to commute/relocate:

- Manchester: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Will you require sponsorship to work in the UK? (Now or in the future)

**Experience**:

- GMP manufacturing: 1 year (required)

Work authorisation:

- United Kingdom (required)

Work Location: In person

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