Job Title: Specialist in QA Validation
Hobson Prior is collaborating with a Biotech company seeking a Specialist in QA Validation to oversee the production and distribution of Gene Therapy medicinal products. The chosen individual will guarantee that processes and equipment meet validation and qualification standards as per relevant regulations.
Please note that to be considered for this role, you must have the right to work in this location.
Responsibilities:
1. Prepare and Maintain Site Validation Plan: Develop and maintain a comprehensive site validation plan, ensuring adherence to regulatory requirements.
2. Maintain and Archive Validation/Qualification Documentation: Organize and store all validation and qualification documents, ensuring easy access and compliance with regulations.
3. Collaborate with Other Departments: Work closely with other departments to ensure understanding and adherence to validation project plans.
4. Communicate and Provide Training: Train staff and contractors on the required validation standard, ensuring consistency and compliance across the organization.
5. Review and Approve Validation Protocols and Reports: Review and approve validation, qualification protocols, and reports to ensure accuracy and compliance.
6. Provide Supervision to Project-Related Deviations: Offer guidance and support to project teams during deviations, ensuring minimal disruption to operations.
7. Assist Generation of Process and Equipment Qualifications: Assist in developing process and quality control (Q/C) equipment installation, operational, and performance qualifications.
8. Interface with External Consultants and Partners: Collaborate with external consultants, partners, suppliers, and contractors to ensure successful process and equipment validation.
9. Provide Q/A Assistance to Data Integrity Compliance Activities: Support data integrity compliance activities across the site, ensuring accurate and reliable data.
10. Assist Regulatory Inspections and Third-Party Audits: Assist during regulatory inspections and third-party audits, ensuring preparedness and compliance.
11. Ensure Compliance with Quality Documents: Ensure personal work complies with Good Manufacturing Practice (GxP), Data Integrity, and Good Documentation Practice (GDP) regulations.
Key Skills & Requirements:
1. BSC in Science / Engineering: Possess a Bachelor of Science degree in Science or Engineering.
2. Strong Quality Assurance Background: Demonstrate a strong Quality Assurance background, working in a Pharmaceutical or Biotech Production environment within sterile manufacturing.
3. Extensive Experience in QA Technical Support: Show extensive experience providing Quality Assurance technical support and oversight to validation and qualification activities.
4. Knowledge of Cell Culture-Based Manufacturing Techniques: Have knowledge of cell culture-based manufacturing techniques and requirements, particularly in cellular and gene therapies.
5. Experience with Risk Assessment Tools: Utilize risk assessment tools, including Failure Mode and Effects Analysis (FMEA).
6. Ability to Balance Business Needs with Regulatory Challenges: Demonstrate the ability to balance business needs with regulatory challenges, ensuring compliance while meeting deadlines.
7. Proven Ability to Work in Ambitious Environments: Showcase proven ability to work successfully in ambitious, deadline-driven environments, handling multiple tasks simultaneously.