This position as Validation and Commissioning Manager is a challenging and rewarding position with a successful international firm.
You will enjoy this position if you enjoy these types of activities:
• Managing CQV and CSV activities on site, along with re-qualification requirements.
• Ensuring effective instrument calibration.
• Providing validation support to a range of site capital projects
To apply for the job, you will need a thorough understanding and experience of validation requirements in pharmaceutical manufacturing. You will also have had experience managing small teams of engineers and technicians.
Responsibilities also include:
• Responsibility for commissioning, qualification and validation of all process equipment, facilities and utilities on site.
• Ensure that the Capex team is provided with adequate validation support at all times.
• Ensuring compliance with current industry regulations and validation guidelines
• Managing department performance against defined KPIs.
• When required, support the Technology Transfer initiatives for incoming new products.
• Implement training programs and maintain up to date training records for all team members personnel.
• Provide regular reports on the activities of the validation group to senior management
• Responsibility for the site programme for instrument calibrations, ensuring instruments remain in a calibrated status.
• Develop and implement plan for instrument calibrations.
• Drive continuous improvement in the area of instrument calibration.
• 3rd level Engineering or Science Degree, or equivalent
• At least five years validation management experience in a pharmaceutical environment
• Strong awareness of validation practices and regulatory guidelines for a pharmaceutical facility.
• Experience of writing validation plans, design documentation, system configuration, system testing and related areas
• Proven ability to lead and direct others, as well as the ability to work as part of a team.
• Ability to work in a highly regulated industry and strive for continuous improvement.
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