Batch Record Reviewer

2 weeks ago

Edinburgh, United Kingdom RoslinCT Full time

**Batch Record Reviewer**
**Location**: Edinburgh BioQuarter, Little France

**Who are we?**

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here

**Why join us?**
- The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career
- A generous salary package - we reward our people at the level they deserve
- 31 days of annual leave, plus 4 public holidays which increases with tenure
- A competitive company pension scheme to help you save for the future
- Group Life Cover - you are automatically covered for three times your basic salary to give you and your family peace of mind
- Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us
- Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

**Your new role**
- An exciting opportunity to join our team as a **Batch Record Reviewer**:

- A key role which will be responsible for performing manufacturing GMP documentation reviews by the mandated closure date
- Review executed manufacturing batch documentation (batch records, in-process data, and environmental monitoring data)
- Ensure GMP compliance and adherence to SOPs through the review and approval of executed manufacturing documentation
- Using a 'right first time' approach, assure all comments and annotations are clear and concise
- Communicate any quality events and provide regular feedback on findings during audit
- Partner with colleagues in investigations, deviations, discrepancies, and technical problem solving as required
- Work closely and collaboratively with the Operation Quality Improvement team to identify appropriate continuous improvement opportunities
- Work diligently to ensure timely closure of packs for batch disposition and shipment to patient
- Evaluate trends and work pro-actively and collaboratively on targeted initiatives to reduce data errors and deviations
- Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills
- Provide timely communication and work with Lead Biotechnologists, Section Managers and the Training Academy to conduct sharing sessions with personnel on batch data audit outcomes, investigation outcomes, impacts and CAPAs.

**About you**
- Experience of cell culture methods and techniques
- Excellent working knowledge of GMP regulations, particularly in respect of aseptic processing, documentation and record management
- A strong working knowledge of UK, EU, and FDA regulations
- You will have experience with technical writing and addressing GMP audit findings
- Exceptional organisational and planning skills with the ability to multi-task in a fast-paced environment
- Excellent communication and interpersonal skills, with the ability to build strong working relationships internally and externally
- You will be able to create a positive environment through self-awareness and social skills
- Able to effectively manage and influence stakeholders’ and customer expectations
- You will be organised, with excellent administration and record-keeping skills
- Ability to learn and share knowledge with the management team and the wider team where appropriate
- Excellent attention to detail with a real desire to continually develop and improve our processes.

**Qualifications**

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