Pfizer Validation Lead in Newbridge, Ireland
Closing date for applications: 25th July 2018
Situated in Co. Kildare, Pfizer Newbridge is an integral part of the global oral solid dose network; manufacturing tablets and capsules for world markets using highly complex processes. This site has been an established leader in the supply of medicines for over twenty years and is currently expanding its portfolio. The Technical Services team is recruiting for colleagues to work with us at this exciting time for the facility.
We support the commercial supply and technical transfer of products using a range of technologies such as Process Analytical Technologies and Advanced Process Control. We continuously improve and enhance our facility through the execution of complex projects introducing next generation manufacturing processes. These are deployed using six sigma and lean methodologies.
We have a pilot scale plant (the Technology and Innovation Centre) with the capability of carrying out development at 1kg to 50kg scale across all principle unit operations. We own the validation of the manufacturing and cleaning processes which supply all markets including the USA, EU and Asia. We work in a fast paced environment where learning and personal development are actively encouraged.
We pride ourselves on our culture of high performance team work and innovation which enables the business to deliver on its commitments.
Summary of the Validation Lead position:
This role provides validation leadership to a team supporting Solid Oral Dose commercial and Product Transfer Project Teams. The company has a diversified commercial product portfolio across multiple technology platforms.
A key focus of this role is the achievement validation excellence through robust and reliable processes to ensure compliance with Pfizer Quality Systems (PQS) and cGMP regulatory expectations.
The responsible person will provide strategy and project oversight for validation activities (Process and Cleaning). This includes standardization of the approach to validation, ensuring consistency of application in accordance with agreed timelines and schedules.
Provides validation leadership to the Process Team leads to support change control activities and oversee implementation. Is the owner of the Site Validation Master Plan (VMP) and is accountable for ensuring that the site remains in compliance.
Liaises with network SMEs through Validation Community of Practices (CoP) and Common Interest Groups (CIGs) to share best practices and identify next practices to ensure site remains current and compliant with regulatory expectations.
Provide validation expertise and guidance for new processes and products. Represent Technical services in internal and external audits and inspections.
Identify Continuous Improvement opportunities and progress Continuous Improvement projects in validation systems and processes.
In addition the successful candidate should be aware of new methodologies pertinent to the function and be able to introduce them with limited supervisory input. The introduction of new technologies and innovative thinking is actively encouraged at the Newbridge site.
Educated to degree level in Science, Pharmacy or a related technical discipline.
Minimum of 8 years Validation experience in the Pharmaceutical industry, preferably in solid oral dose manufacture would be advantageous.
Please note due to annual site shut down there may be a delay in contacting you re your application and we hope to be in contact early-mid August.
There is no relocation support available for this position and a valid work permit is required.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.