Hobson Prior are looking for a QA Associate - Validation and Tech Transfer to join a fantastic biotech industry on a permanent basis located in London. Our client is focused on improving the lives of patients through cutting-edge science.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Interface with other departments such as Engineering, QC, Operations, Warehouse and MSAT (Process Development) to ensure that validation project plans are understood and in keeping with site objectives.
• Review and approve tech transfer, validation, qualification protocols and reports.
• Deputise for line manager as directed.
• Maintain understanding of cGMP, Good engineering practices and guidance in relation to all aspects of validation across manufacturing, analytical laboratories, and facilities.
• Support the generation of Process Validation, Analytical Method Validation and Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies, and reports for Quality.
• Interface with external consultants and partners as directed by QA Specialist, Validation & Tech Transfer, suppliers, and contractors to ensure successful process and equipment validation.
• Provide QA support to data integrity compliance activities across the site.
• Write or assist in writing of the company policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.
• Maintenance and archiving of Validation documentation.
• Support Regulatory Inspections and third-party audits.
• Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
• Any other assigned duties.

Requirements:

• The ideal candidate requires a minimum of a BSc in Science / Engineering.
• The individual must have an established track record in delivering robust and regulatory compliant Tech Transfer and Validation Plans and Protocols
• Extensive experience of GxP compliance requirements.
• The successful candidate must have experience in GMP manufacture of parenteral products, with an emphasis on aseptic manufacturing.
• Experience of GMP manufacturing requirements, the validation of facilities, processes, equipment and analytical methods.
• Experience in using risk assessment tools including FMEA.
• Must be well spoken in English.
• Able to Interact with other departments and personnel across the business both orally and in writing, demonstrating good interpersonal skills.
• Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills.
• Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met.
• Ability to balance needs of the business with the needs of the Regulatory challenges.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.