Job DescriptionCalling all QC Validation professionals, this is a unique opportunity to make real change within the Biotech field.
I'm working with a client in London UK who is a leading Biotech company. You will be closely working with a wider team to make real change within organisations within the biotech field. All while representing company standards like innovation, quality and excellence.
Key Responsibilities:
- Lead the development and validation of both established and innovative analytical test methods for current and newly developed gene therapy products.
- Act as the subject matter expert for lifecycle management of analytical assays, equipment, and materials, including in-process samples and finished products.
- Develop and manage qualification/validation projects, ensuring all supporting documentation aligns with compliance requirements.
- Ensure all methods are validated and executed in QC GMP laboratories, adhering to regulatory standards and data integrity requirements.
- Support the validation of methods for raw material testing and sampling booth activities.
- Manage the implementation of test methods, ensuring timelines are met to facilitate the seamless launch of new products.
- Oversee external testing activities to ensure compliance with GMP standards.
- Maintain effective communication with key stakeholders, ensuring the timely update of information folders with the latest versions and relevant communications.
- Facilitate the development and delivery of training on new technologies or methodologies introduced to the facility.
- Conduct routine assessments of analytical methods to ensure their proper application and performance.
- Provide support for employee training as needed.
Job Description:
- Support the maintenance of the Quality Management System, ensuring document control and the integrity of all generated data.
- Assist with managerial requests and handle ad-hoc tasks as required.
- Ensure compliance with Quality, Safety, and Environmental standards and procedures within the designated area.
- Follow procedures, including Health and Safety protocols and GMP regulations.
- Track, monitor, and meet personal KPIs, objectives, and targets within specified timelines.
- Ensure both your work and the team's adhere to GMP, Data Integrity, and Good Documentation Practices (GDP), following applicable procedures.
- Ensure timely and compliant completion of all GMP documentation (e.g., Issues, CAPAs, Change Controls, BMRs, and audit/inspection actions) in your area of responsibility, ensuring they are right-first-time (RFT).
Requirements:
- Degree in Human Health or Sciences equivalent relevant work experience
- Experience in a validation role in the Biotech or Pharma industry
- Previously managed a team
- Experience working on several projects
- 5+ experience working in a GMP environment
- Willing to occasionally travel to Ireland