Berkley Pharma & Life Science are currently seeking a Validation & Documentation Control Manager for our client a global pharmaceutical company based in Dublin.
Ref: 5040181
Role/Opportunity:
• Seeking an experienced Validation and Systems specialist with experience in document control systems will be responsible for establishing and maintaining the Good Manufacturing Practice (GMP) status of manufacturing facilities and equipment used in the facility in line with local business needs and established MGRG procedures.
• Additionally will implement and manage MGRG documentation systems (including training records) to ensure that facility and equipment operations, process development and clinical manufacturing activities are in line with regulatory expectations and compliant with expected standards of GMP.
Skills/Experience:
• Minimum of a third level qualification in Chemistry or related discipline
• At least 5 years relevant technical experience in a highly regulated environment (IMB/FDA)
• Track record in managing and motivating a team and delivering results through people.
• An understanding of Lean Principles/Operational Excellence tools and “hands on” implementation of same in a pharmaceutical environment.
• Strong organisational skills with the ability to multitask and prioritise workload in a fast moving environment
• Excellent verbal, written and interpersonal communication skills with the ability to interact effectively at all levels within the organisation
• Thorough and contemporary understanding of equipment qualification processes applied to GMP manufacturing equipment and facilities
• Experience of commissioning and qualification of complex and bespoke manufacturing technology.
• Practical experience of commissioning and qualification of GMP manufacturing facilities including selection and supervision of third party organisations providing specialist technical services.
• Experience of management of documentation control and management systems.
• Experience of implementation of lifecycle management approach to validation of facilities and utilities in a pharmaceutical environment.
• Maintains a contemporary understanding of cGMP regulations/guidance in relation to all aspects of qualification of processes and equipment and manufacturing technology development.
Berkley Pharmaceutical and Life Sciences is a specialist recruitment consultancy which recruits pharmaceutical, clinical and medical device professionals throughout Ireland, Asia, UK and Australia
For more information go to http://www.berkley-group.com
To apply: If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Lisa Fitzsimons on +353 (0)21 4289610 or send your CV to engineering@berkley-group.com
