The Validation Manager is responsible for setting strategy and policies, and oversight of the Validation Department and programs and related activities including: Qualification and re-qualification of facilities, utilities, equipment, computerized systems, cleaning, disinfection, process validation, requalification … A strong focus is on sterility assurance (validation of steam/dry heat/gamma/EO sterilization, media fill, smoke testing,…).The scope includes all regulated areas of manufacturing.
In this role, your responsibilities will be as follows:
o Manage staff and workload of the validation team. Provide coaching, training and mentoring for routine and complex activities.
o Development and implementation of strategy and policies related to validation. Development and oversight of the execution of validation related documents throughout the system, including development of a comprehensive validation master plan covering equipment, utilities, sterilization, cleaning, aseptic processing, cleanroom qualification, computerized system validation, ...
o Support change control, investigations, and MBR’s and SOP’s updates. Determine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality, efficacy, and data integrity using a variety of tools.
o Represent the validation group and defend policies, program, and validation documentation during audits, regulatory inspections. Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed system, process, facility or procedure. Provide validation expertise for issue resolutions to support deviations or CAPA’s and audit findings.
o Develop and co-approve cGMP documents including, but not limited to, Master Validation Plans, SOPs, protocols and forms to improve validation efficiencies.
o Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
o Ensure that all team members comply with safety rules and regulations.
o Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
o Requires collaboration with cross functional team members, must be able to balance normal stress to meet deadlines for various validation projects.
• You have a master's Degree in Science (e.g. Chemistry, Pharmacy, Agriculture) or equivalent.
• You have 3 to 5 years of experience in a pharmaceutical (sterile) manufacturing site.
• Experience in a cGMP environment is an asset. Experience in (medical device) quality & regulatory affairs is an asset.
• Ability to establish a validation strategy to manage multiple projects effectively and efficiently.
• Possess expert knowledge in equipment validation and calibration and broad knowledge related to quality assurance.
• You have good people management skills.
• Excellent written and verbal communication skills including presentation skills in English and Dutch.
We offer you a challenging, international and interdisciplinary work environment. Investment in people is a priority for Novartis. We offer a range of possibilities for personal development and career opportunities within the group to motivated, qualified people. We offer you a competitive salary and benefit package. Your office will be based in Puurs. Novartis supports a flexible work-life integration.