Validation Manager Career Profile

Validation Manager

• To manage all operational validation activities within the client's organisation.
• To continue to develop and implement a compliant validation strategy for our client.
• To continue to develop and implement an efficient compliant and cost effective calibration and maintenance programme.
• To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
• Be capable of delivering high level reporting to the client's directors.
• Manage the process for the creation of documentation and requirements to include but not limited to the following:
• Computer Systems Validation Plans
• Equipment Validation Plans
• Cleaning Validation Plans
• Utility/Facility Validation Plans
• Components Area Validation Plans
• Tissue Business Master Validation Plan
• Despatch Validation Plans
• Environmental Monitoring Validation Plans
• Quality Control Validation Plans
• Scheduling, Planning and review of validation activities.
• Manage all facets of assigned validation projects while maintaining strong communication with client representative on project status and assistance needed.

• Third level degree in a science/engineering/computer subject as a minimum.
• At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry.
• Good understanding and application of GMP and regulatory requirements.
• Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.
• Excellent communication / interpersonal skills
• Previously have managed or supervised a team of experienced engineers in a similar industry.
• Be a motivator and leader for such a team.
• Attention to detail.