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Senior Gmp QA Associate
2 weeks ago
**GMP Senior QA Associate**
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.
This is a full time, permanent position, and a new role, based across 2 sites Leeds (West Yorkshire) and Manchester.
**Main Responsibilities**
- Assisting Production and Pharmacy in the completion of Events, CAPAs, Risk Assessments and Self
- Inspections.
- Ensure actions arising from Events, CAPAs, Risk Assessments, Self
- Inspections and meeting minutes are followed up to completion.
- Generation, review and approval of process risk assessment
- Completion of Self-Inspection and Vendor Audits
- Assessment and maintenance of Vendors and Vendor files
- Completion of Critical Product Risk Assessments and component approval
- Gap analysis of processes, regulations and guidelines. Implementation of the required action from the gap analyses
- Facilitation of quality and process improvements
- Generation and review of validation protocols and reports
- Assisting in the implementation of validated systems, processes or equipment
**Key Skills and Requirements**
- Minimum of 5 years’ experience in Quality Assurance
- Good interpersonal skills
- Very good skills with Microsoft Office (e.g., Word, Excel)
- The ability to write clear and concise reports
- Good attention to detail and excellent organisational ability
- Sufficient initiative to be able to work alone and with a team
- GMP Production experience is must
- Background in Microbiology, Chemistry or similar life science would be an advantage
- Experience in a clinical environment or specials manufacturing is a must
**BENEFITS**:
- 12-month Maternity Cover Contract
- 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
**Benefits**:
- Free parking
- On-site parking
- Private medical insurance
Schedule:
- Monday to Friday
**Experience**:
- Quality assurance: 5 years (required)
Work authorisation:
- United Kingdom (required)
Work Location: In person
Reference ID: HR222
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