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For Companies At a Glance
- Tasks: Manage QA documentation and support the MasterControl system for compliance and training.
- Company: Join a leading company in the pharmaceutical sector focused on quality assurance.
- Benefits: Enjoy flexible working options, training opportunities, and a supportive team environment.
- Why this job: Be part of a dynamic team ensuring quality standards and making a real impact in healthcare.
- Qualifications: 3 years in a GxP environment; strong IT skills and experience with electronic QMS required.
- Other info: Opportunity to develop your skills in a regulated industry with a focus on continuous improvement.
The predicted salary is between 36000 - 60000 £ per year.
Your mission
Purpose of Job
- Act as the QA Documentation Controller for the business, ensuring that files stored and archived both within the electronic Quality Management System (eQMS; MasterControl) and outside of the eQMS are maintained appropriately according to relevant procedures.
- Support validation of the MasterControl system to assure compliance across all sites; supporting project and upgrade re-qualification activities.
- Provide first line support to end users for the MasterControl system, providing training as required.
- Support the Quality Assurance team in other activities where requested.
Job Description
Major Activities
- Perform daily administrative tasks for the MasterControl System, including, but not limited to:
- User Management
- Document Review, Approval & Release
- Reviewing Batch documentation
- Setup and maintain training courses and curriculum
- Workflow Management
- User Support
- eQMS and Document support during Regulatory, Competent authority and Third-Party audits.
- Issuance of Batch Manufacturing Records and Batch Numbers.
- Hard Copy Document Retention and Archiving.
- Organise and manage QA Document Control visibility and activities.
- Author and maintain procedural documents related to management of documents within the QMS
- Maintain documentation held externally from the QMS, including document issue, return and archiving as required
- Support QMS projects, including partaking in computer system validation activities where required
- Develop and deliver training related to the QMS and any other role related training as required
- Support Periodic System Reviews as required
- Provide Key Performance Indicator Reports for departments as required.
Key Performance Indicators
- The MasterControl document control system is maintained in a validated state
- General MasterControl administrative tasks are completed contemporaneously e.g. users are provided with access when applicable, documents are reviewed and approved in a timely manner to facilitate the progression of GxP activities
- All users are appropriately trained and supported when using the MasterControl Software.
- Documentation maintained outside of the MasterControl system is maintained in an easily retrievable state
- Any records overdue as escalated appropriately to facilitate progression
- Attend any required training as defined by line manager
- Metrics Reports are accurate and provided in a contemporaneous manner as required
Key Job Competencies
- Experience in working with electronic Quality Management Systems for document and process management
- Fully computer literate, proficient with standard software packages on an advanced level (such as Microsoft applications, specifically Excel, Word, PowerPoint) and adaptable to new software packages / web applications
- Experience in developing and delivering end user training, preferred system training
- Excellent interpersonal skills
- Good organisational and time management skills and able to demonstrate flexibility and adaptability
- Experience working with high volumes of documentation, electronic and paper
- Good attention to detail for data entry tasks and understanding of Good Documentation Practices
- A basic understanding of computer system validation in the pharmaceutical sector
- Experience and knowledge of working in a regulated environment, specifically with regards to record retention
- Knowledge of GCP and GMP with regards to QMS activities
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state
Job Background
- Minimum of 3 years experience working in a GxP environment
- IT literate, experience managing and operating an electronic QMS
- English language required
Why us?
#J-18808-Ljbffr
QA Doc Controller employer: Meiragtx
Contact Detail:
Meiragtx Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Doc Controller
✨Tip Number 1
Familiarise yourself with MasterControl and other electronic Quality Management Systems. Understanding the functionalities and common issues users face will help you stand out during interviews, as you'll be able to demonstrate your proactive approach to learning.
✨Tip Number 2
Brush up on your knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP). Being well-versed in these areas will not only boost your confidence but also show that you are serious about compliance and quality assurance.
✨Tip Number 3
Prepare to discuss your experience with training and user support. Think of specific examples where you've successfully trained others or resolved user issues, as this is a key part of the role and will highlight your interpersonal skills.
✨Tip Number 4
Network with professionals in the QA and pharmaceutical sectors. Engaging with industry groups or forums can provide insights into the role and may even lead to referrals, increasing your chances of landing the job with us.
We think you need these skills to ace QA Doc Controller
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a QA Doc Controller. Familiarise yourself with the key activities mentioned in the job description, such as document management and user support for the MasterControl system.
Tailor Your CV: Highlight your experience with electronic Quality Management Systems and any relevant GxP experience. Be specific about your skills in document control, training delivery, and your proficiency with software like Microsoft Excel and Word.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and how your background aligns with the company's needs. Mention specific examples of your past experiences that demonstrate your attention to detail and organisational skills.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that your documents are clear, concise, and free from typos, as attention to detail is crucial for this position.
How to prepare for a job interview at Meiragtx
✨Know Your eQMS Inside Out
Familiarise yourself with the MasterControl system and its functionalities. Be prepared to discuss your experience with electronic Quality Management Systems, as well as any specific tasks you've performed related to document control and user management.
✨Highlight Your Training Experience
Since the role involves developing and delivering training, be ready to share examples of training sessions you've conducted. Discuss your approach to ensuring users are comfortable with the system and how you adapt your training style to different audiences.
✨Demonstrate Attention to Detail
Given the importance of Good Documentation Practices in this role, prepare to showcase your attention to detail. You might be asked about how you ensure accuracy in documentation and what steps you take to maintain compliance with GMP and GDP.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think of examples where you've had to manage high volumes of documentation or support users during audits, and be ready to explain your thought process and actions taken.
