Gmp QA Document Controller

4 weeks ago

Leeds, 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’ve an exciting opportunity for a hard-working individual who is capable of working independently and as team to join our GMP QA Department as a QA Document Controller. To ensure cover across all GMP Sites regular travel to our Manchester site may be required.

Main Responsibilities
- Issuing, release and maintenance of the GMP Unit SOPs with applicable regulations.
- Management of the GMP Unit SOPs, Forms and Template
- Issuing release and maintenance of GMP Unit specific documentation
- Assisting with the hosting of external audits or inspections from clients or regulators.
- Assisting in facilitating quality improvements
- Issue and Reconciliation of production forms for use
- Maintenance of the GMP Training programs, including reminders and follow up
- Maintenance of the GMP training log and trainer status
- Creating new starter training files and organising induction training

Key Skills and Requirements
- Previous experience in GMP Production environment
- Good interpersonal skills
- Very good skills with Microsoft Office (eg Word, Excel)
- Good attention to detail
- Good communication and excellent organisational skills
- Sufficient initiative to be able to work alone and with a team
- Some experience in a clinical environment would be useful

BENEFITS:

- Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
- Health Insurance
- Free onsite parking
- 25 days annual leave (increasing in increments to 30 days after 6 years service)
- Your birthday off work

**Job Type**: Part-time

Expected hours: 30 per week

**Benefits**:

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

Schedule:

- 8 hour shift

**Experience**:

- admin support in GMP environment: 1 year (required)

Work authorisation:

- United Kingdom (required)

Work Location: In person

Reference ID: HR308

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