At a Glance
- Tasks: Lead quality control and batch release for pharmaceutical products, ensuring compliance with regulations.
- Company: Join a dynamic and growing pharmaceutical company making waves in the industry.
- Benefits: Enjoy a hybrid work model with flexible options and opportunities for professional growth.
- Why this job: Be part of a mission-driven team focused on quality and regulatory excellence in healthcare.
- Qualifications: Must be a qualified QP with experience in GMP compliance and quality assurance.
- Other info: This is an urgent role; apply quickly to seize this exciting opportunity!
The predicted salary is between 36000 - 60000 £ per year.
RRxCo has been exclusively retained by an exciting and growing pharmaceutical company to help them find the next QP. This role is only suitable for candidates who are already qualified as a QP and can be in the Greater London (west) office weekly. Although it will be a hybrid position.
The Qualified Person is instrumental in performing the release activities for the company and leading batch assessments to ensure releases are carried out efficiently, in a timely manner and meeting relevant quality and regulatory standards. Maintaining compliance with the company’s GMP Quality Management System, manufacturing authorisations, all relevant UK/EU regulatory and legislative requirements with the Quality Assurance (QA) activities.
- Activities as a Qualified Person in quality control and batch release of pharmaceutical products manufactured and tested by CMO and 3rd party laboratories.
- Promoting compliance and adherence to Quality Policies, Standard Operating Procedures (SOPs) and training programmes.
- Implementation of best practices to ensure GMP compliance for all products marketed.
- To perform internal and external audits (including manufacturer, packaging and suppliers' sites) and supporting authority inspections as required.
- Planning and coordinating the implementation of any new legislative regulatory requirements in a timely fashion.
- In conjunction with the Regulatory department, manage the relationship with MHRA regarding quality issues, batch recalls, and requests for information.
- Completion of QP declaration and management of Quality functions around APIs.
- Review of any quality-related documentation associated with batch certification process, including but not limited to AMTS, Validation, audit report, OOS reports, TSE/BSE and Nitrosamine reports.
- Review CMO batch records, analytical C of A to a high level in order to perform batch certification in accordance to all aspects of EU guide Annex 16.
- Ensuring any deviations in CMOs manufacturing, quality procedure are managed and notified in accordance with the defined reporting system before any product is certified.
- Approval of CMOs manufacturing change controls and ensuring compliance to the regulatory dossier.
- Ensuring that the necessary quality control checks and tests have been performed in line with manufacturing procedure, including review and approval of laboratory investigation reports.
- Offering advice and guidance with respect to regulatory expectations and recognised best practice.
- Reviewing technical agreements on behalf of the business, in line with the Product Launch Managers requirements.
- Performance of recall and Mock recall ensuring records are effectively maintained to help manage this process when required.
- Helping to improve the quality management system and its maintenance, promoting and helping in the continued development of a quality culture throughout the organisation.
- Writing, reviewing, updating and approving of Standard Operating Procedures.
- Providing training to employees as required, to increase understanding of regulatory GMP requirements and that training records are maintained as per business requirements.
This is an urgent role so for full details please get in touch as soon as possible.
Qualified Person - Pharmaceuticals employer: Confidential
Contact Detail:
Confidential Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Qualified Person - Pharmaceuticals
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who are already working as Qualified Persons. Attend industry events or webinars to connect with potential colleagues and learn about their experiences.
✨Tip Number 2
Familiarise yourself with the latest UK and EU regulatory requirements related to GMP compliance. This knowledge will not only boost your confidence but also demonstrate your commitment to staying updated in this fast-paced field.
✨Tip Number 3
Prepare for potential interviews by reviewing common questions related to batch release processes and quality assurance. Practising your responses can help you articulate your experience and expertise effectively.
✨Tip Number 4
Showcase your ability to implement best practices in quality management during discussions with recruiters. Highlight any specific examples from your past roles where you successfully improved compliance or efficiency.
We think you need these skills to ace Qualified Person - Pharmaceuticals
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your qualifications as a Qualified Person, including relevant experience in batch release activities and compliance with GMP standards. Use specific examples to demonstrate your expertise.
Craft a Strong Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention your familiarity with UK/EU regulatory requirements and how your skills align with the responsibilities outlined in the job description.
Highlight Relevant Certifications: Clearly list any certifications or training related to quality assurance and regulatory compliance. This will reinforce your suitability for the position and show that you are up-to-date with industry standards.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in the pharmaceutical industry.
How to prepare for a job interview at Confidential
✨Showcase Your QP Qualifications
Make sure to highlight your qualifications as a Qualified Person. Discuss your experience with batch release activities and how you've ensured compliance with GMP standards in previous roles.
✨Demonstrate Regulatory Knowledge
Be prepared to discuss your understanding of UK/EU regulatory requirements. Familiarise yourself with the latest changes in legislation and be ready to explain how you would implement these in practice.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills. Think about past experiences where you had to manage deviations or quality issues, and be ready to explain your approach and the outcomes.
✨Emphasise Team Collaboration
This role involves working closely with various departments. Highlight your experience in cross-functional teams and how you’ve successfully collaborated with regulatory and quality assurance teams in the past.