Mantell Associates
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
Process Validation Expert – 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.