Quality (Validation, Process Consultant)

Mantell Associates is partnered with a leading Biotech organisation in their search for a Quality (Validation, Process Consultant) to support Process Performance Qualification (Process Validation) activities in accordance with Regulatory requirements.

Quality (Validation, Process Consultant) – Responsibilities:

• Develop pre-validation / validation strategy, including the strategy for supportive studies
• Coordinate activities between all departments involved in individual activities of drug substance manufacturing process validation and cleaning validation
• Create protocols and validation reports
• Initiate monitoring and continuous process verification phase and compilation of the first APQR
• Act as single point of contact for a given validation process
• Contribute to the overall strategy and plans of projects scope, including the creation of schedules and budgets
• Develop validation plans, scientifically sound technical strategies (with validation team) and contingency plans, identifying obstacles and proposing possible solutions
• Planning of resource needs (full time, investment, external costs), strategies and schedules

Quality (Validation, Process Consultant) – Requirements:

• Higher education in the field: biotechnology, pharmacy or related
• Strong professional experience in the biotechnology or pharmaceutical/medical industry
• Experience in validation of manufacturing processes and cleaning validation
• Excellent knowledge of GMP, EMA and FDA requirements and current technology transfer guidelines
• The ability to organise work well and to cooperate in a team
• Ability to identify and solve problems independently

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.