Description
Our client, a rapidly expanding and well known biologics company, require a QAV Manager to lead a technical transfer/ duplication of a cell culture manufacturing process to mainland Europe due to unprecedented growth and demand for their product.The Consultant/ Manager QA Validation-Drug Substance is a long term contract opportunity and will be responsible for the Quality Assurance of all validation activities associated with the technical transfer of cell culture drug substance manufacturing processes to a mainland Europe contract manufacturing organisation. This includes ensuring that all transfer plan elements are appropriately qualified and that the transfer is executed in accordance with cGMP.
This is a long term contract opportunity where the consultant will be primarily expected to be travelling to mainland Europe for onsite support during the key aspects of the transfer activity with nominal travel to Dublin, Ireland.
Note: This role requires 60% travel as it will be partially based at a single location in mainland Europe
Principal Responsibilities
• Leadership in the review of the validation strategy at the contract manufacturing organisation, recommend changes to enhance compliance to global regulatory requirements and ensure these changes are delivered.
• Project management of the quality assurance validation aspects of the technical transfer activity.
• Evaluate and approve equipment/process/cleaning qualification or validations protocols and reports.
• In plant oversight of the manufacture of engineering and process validation batches at the drug substance contract manufacturing organisation.
• Support the approval of deviations, change controls and CAPAs arising from process validation activities.
• Support the contract manufacturing organisation pre-approval inspection audits, as necessary.
• Develop and issue quality metrics pertaining to the process validation activities.
• Responsible for documenting and reporting compliance issues identified during the technical transfer activity to senior management.
Qualifications
• Extensive experience in the pharmaceutical industry.
• Must have direct experience of validation/qualification during inter-site technical transfers of drug substance manufacturing processes in a cGMP environment.
• Must have direct experience of drug substance manufacturing processes validation in a cGMP environment.
• Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance manufacturing process validation.
• Must have experience working with contract manufacturing organisations.
• Experience leading quality assurance activities as part of complex, multifunctional projects at contract manufacturing organizations is desirable.
• Direct experience presenting and defending drug substance manufacturing process validation to regulatory agencies such as FDA and EMA is desirable.
Education
• Bachelor’s degree required; preference given to candidates with advanced degrees; ten or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.