Batch Record Reviewer

3 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**

**Next Steps**
- At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners._- _

  • Batch Record Reviewer

    4 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...

  • Records Manager

    2 weeks ago

    Edinburgh, United Kingdom Page Personnel Full time

    Our client is looking for a Records Manager Client Details A leader in their field Description Records Management Support the business in all matters relating to document and records management ensuring that all processes and polices are in place and adhered to and that the Records Management Plan is implemented and reviewed...

  • Records Manager

    3 days ago

    Edinburgh, United Kingdom Page Personnel Full time

    Our client is looking for a Records Manager Client Details A leader in their field Description Records Management Support the business in all matters relating to document and records management ensuring that all processes and polices are in place and adhered to and that the Records Management Plan is implemented and reviewed regularly. 2. Archiving ...

  • Student Records Officer

    1 month ago

    Edinburgh, United Kingdom University of Edinburgh Full time

    **UE05 **£25,285 - **£28,929 **Per Annum** **University Secretary's Group / Registry Services / Student Systems & Administration** **Open Ended (Permanent)** **Full Time - 35 Hours Per Week** We are seeking a Student Records Officer to join the Student Record Operations Team. **The Opportunity**: The post holder will provide exceptional levels of...

  • Records Management Manager

    3 days ago

    Edinburgh, United Kingdom Page Personnel Full time

    A leader in their field Records Management Support the business in all matters relating to document and records management ensuring that all processes and polices are in place and adhered to and that the Records Management Plan is implemented and reviewed regularly. Archiving Manage the offsite data storage working with external providers to ensure an...

  • Head of QA

    1 month ago

    Edinburgh, United Kingdom Hobson Prior Full time

    **Salary**: £70000 - £80000 per annum**Job type**: Permanent **Location**: Edinburgh, Scotland **Function**: Quality Assurance, Quality Engineer **Posted**:07/08/2023 **Ref**: BBBH23308 - Hi I'm Ben , I manage this role Hobson Prior are looking for a Head of QA to join a pharmaceutical corporation on a permanent basis located in Edinburgh. Our...

  • Manufacturing Biotechnologist

    1 month ago

    Edinburgh, United Kingdom RoslinCT Full time

    **Manufacturing Biotechnologist** **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...

  • Vacancy for Senior Data Engineer at National Records of Scotland

    1 month ago

    Edinburgh, United Kingdom Digital Preservation Coalition Full time

    Vacancy for Senior Data Engineer at National Records of Scotland Vacancy for Senior Data Engineer at National Records of Scotland 30 July 2021 Edinburgh Full-Time Overview National Records of Scotland (NRS) is a Non-Ministerial Department of the Scottish Government, supporting the Registrar General for Scotland and the Keeper of the Records...

  • Manufacturing Biotechnologist

    4 weeks ago

    Edinburgh, United Kingdom RoslinCT Full time

    **Manufacturing Biotechnologist** **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...

  • Senior Quality Control Analyst Analytical

    1 day ago

    Edinburgh, United Kingdom RoslinCT Full time

    Senior QC Analyst – Analytical 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...

  • Senior Quality Control Analyst

    1 day ago

    Edinburgh, United Kingdom Roslin Cell Therapies Limited Full time

    Senior QC Analyst – Analytical 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...

  • Planner

    4 weeks ago

    Edinburgh, United Kingdom Veranova Full time

    Company Description We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing...

  • Associate Msat

    4 weeks ago

    Edinburgh, United Kingdom RoslinCT Full time

    **Associate MSAT (Manufacturing Science and Technology) Scientist** **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...

  • Mainframe System Operations Analyst

    4 days ago

    Edinburgh, Edinburgh, United Kingdom NatWest Group Full time

    Join us as a Mainframe System Operations AnalystHone your analytical skills as you provide support to ensure the operational health of the platform, covering all aspects of service, risk, cost and peopleYou'll be supporting the platforms' operational stability and technology performance, including maintaining any system's utilities and tools provided by the...

  • Mainframe System Operations Analyst

    5 days ago

    Edinburgh, United Kingdom NatWest Digital X Full time

    Join us as a Mainframe System Operations AnalystHone your analytical skills as you provide support to ensure the operational health of the platform, covering all aspects of service, risk, cost and peopleYou’ll be supporting the platforms’ operational stability and technology performance, including maintaining any system’s utilities and tools provided...

  • Mainframe System Operations Analyst

    2 days ago

    Edinburgh, United Kingdom NatWest Group Full time

    Join us as a Mainframe System Operations Analyst Hone your analytical skills as you provide support to ensure the operational health of the platform, covering all aspects of service, risk, cost and people You’ll be supporting the platforms’ operational stability and technology performance, including maintaining any system’s utilities and tools...

  • Mainframe System Operations Analyst

    4 days ago

    Edinburgh, United Kingdom NatWest Group Full time

    Join us as a Mainframe System Operations AnalystHone your analytical skills as you provide support to ensure the operational health of the platform, covering all aspects of service, risk, cost and peopleYou’ll be supporting the platforms’ operational stability and technology performance, including maintaining any system’s utilities and tools provided...

  • Senior Databricks Engineer

    4 weeks ago

    Edinburgh, United Kingdom Version 1 Full time

    Job Description This is an exciting opportunity for an experienced developer of large-scale data solutions. You will join a team delivering a transformative cloud hosted data platform for a key Version 1 customer. The ideal candidate will have a proven track record as a senior/self-starting data engineer in implementing data ingestion and...

  • Manufacturing Technician

    1 day ago

    Edinburgh, United Kingdom RoslinCT Full time

    Manufacturing TechnicianLocation: Edinburgh BioQuarter, Little FranceWho 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...

  • Archivist (Collections)

    4 weeks ago

    Edinburgh, United Kingdom Digital Preservation Coalition Full time

    Vacancy for Collections Development Archivist at abrdn Vacancy for Collections Development Archivist at abrdn Full-Time The abrdn archive collects, preserves and promotes the history of abrdn, all its previous entities and all its subsidiaries. Physical and digital material is acquired, catalogued, preserved and made available to a range of internal...