We are searching for our new Manager of Qualification and Validation

The Validation Manager is responsible for the validation and qualification program at HP Halden Pharma AS. This includes management of the Validation Master Plan, Process Validation, Equipment qualification, Cleaning validation, Filter validation, as well as the Risk Assessment program. The role is responsible for the management, development and oversight of the validation and qualification team.

The position reports to the Technical Director.

The day to day of a Manager for Validation and Qualification could include, but are not limited to, the following:

• Designs and develops policies related to validation and ensures that they are effectively administered and comply with regulatory requirements.
• Responsible for all aspects of Validation including review and approval of the following types of documents, relating to area functions: Failure investigations, Change controls and associated Test Plan documentation, SOPs, Validation protocols and summary reports, and Validation Master Plans
• Interviews, hires, and trains incoming personnel.
• Manages Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks.
• Develops and manages validation budget, contracts, and schedules
• Maintains validation document and software control system.
• Ensures that validation status is maintained for equipment and software use in commercial and clinical manufacturing.
• Organizes Validation resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management.
• Plays a proactive role in developing and applying new approaches and processes to validation strategies.
• Regularly interacts with senior managers and executives to create a broad-based validation program.
• Applies complete functional knowledge and awareness of company goals and objectives

Requirements to education and experience:

• M.Sc. in Process, Chemistry/Biology or similar education.
• Significant experience (~7 years) in commissioning, qualification and validation within the pharmaceutical industry, preferably in a leadership role
• Experience with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site.
• Leadership and interpersonal skills, with the ability to motivate and inspire teams to achieve objectives and drive continuous improvement.
• Excellent communication and presentation skills, with the ability to effectively communicate with stakeholders at all levels of the organization.
• Command of verbal and written English
• Experience from qualification/validation and pharmaceutical production
• Preferably experience from pharmaceutical production and/or control
• Knowledge of commonly used computer systems
• Experience from an international company with cooperation and communicating in different levels in the organization

Personal characteristics:

• Positive mind-set and have an including attitude
• Good communication- and cooperation skills, and ability to communicated between different levels of the organization.
• Proactive and goal oriented
• Organized and quality oriented
• Ability of making decisions

What we offer:

• A healthy balance between work and leisure with flexible working conditions
• Excellent pension and health insurance schemes
• Opportunities to participate in activities organized by the company's sports club
• Access to our corporate cabins at Tanumstrand

Please contact Marcin Krzysztof Artuna if you have any questions related to the position: Marcin.Artuna@halden-pharma.com

If you are interested in the role, please send your application from SF-Careers.

Applicants will be considered on an ongoing basis.