|Job Title:||Validation Manager|
|Contact Name:||John Reid|
|Job Published:||over 3 years ago|
My client a leading Multinational Healthcare Manufacturing company now require a Validation Manager to join their expanding team.
The role of the Validation Manager has a key role to play in the Company?s commitment to quality and efficiency.
This is a permanent role based in Dublin and it comes with a competitive salary and benefits.
Responsibilities of a Validation Manager:
? Manage and coordinate the activities of the Technical services team. The team consists of a Validation Specialist group and a Development lab group.
? Formulate and plan development studies to support new product introduction, continuous improvement and company research objectives.
? Carry out validation activities as outlined in the Site Validation Policy and Site Validation Master Plan and to ensure compliance with Regulatory requirements for validation activities.
? Prepare and control all validation documentation according to the relevant SOPs.
? Co-ordinate the introduction of new products, processes, equipment and systems
? Prepare and implement Installation and Operation Qualification protocols and reports to ensure the effective validation of facilities, utilities, systems and equipment.
? Prepare and implement Process Validation and Performance Qualification protocols and reports and to ensure the effective validation of processes and systems.
? Co-ordinate and prepare/approve cleaning verification and validation protocols and reports and procedures relating to the cleaning program.
? Participate in the site change control system affecting pharmaceutical products and medical devices, ensuring that all changes to validated processes, systems, facilities and utilities are effectively assessed to ensure that regulatory compliance is maintained at all times.
? Assist, individually or as part of a task team, in any process problems and technical investigations as required and to be proactive in terms of contributions to process improvements and efficiencies.
? To liaise with the all other Departments within the Company and with Vendors as required ensuring that project targets are achieved in a timely manner.
? To participate in the preparation of URS and related documents and to coordinate FAT testing at Vendor sites.
? Responsible for overseeing the validation of computerized systems (GMP critical) and the computerized system network.
? Mentor and develop department members in line with the company Continuous Professional development (CPD)Policy
Requirements of Validation Manager:
? Honours degree in science or engineering.
? 5 years post graduate experience working in validation in a regulated environment (pharmaceutical or medical devices).
? Minimum of 2 years supervisory experience.
? Experience in Six Sigma methodologies and have validation experience in the following areas: Computerised systems, Process and cleaning and new products/formulations.
? Proven ability to work in cross-functional team environments, as well as independently.
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / firstname.lastname@example.org/ 01 2302400
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