Process Support Specialist

5 days ago


Tredegar, United Kingdom PCI Pharma Services Full time

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

To take a lifecycle approach in supporting Commercial production & processes so that compliance is maintained at all times and that improvement activity is focused on the most beneficial areas within the facility.

To provide a support function to Operations which coordinates change management, Training, deviation investigation and resolution and process capability improvement in order to maximise right-first-time production and minimise the cost of failure.

The role is also responsible to support development, planning and implementation of continuous improvement programmes.- To support the Life Cycle of, and any changes to, products, processes and systems required in the production of commercial products to GMP standards.- To coordinate activity with other departments to ensure changes are introduced in an efficient way and which ensures maintenance and improvement of product control strategies, quality standards and operational key performance indicators.- Commercial production deviations to be monitored and addressed in a holistic manner to ensure minimisation of waste.- Support the site team during customer and regulatory authority audits and customer meetings where required.- Leading & supporting Continuous Improvement initiatives within Operations- To communicate effectively with internal and external customers and encourage collaboration in problem solving and continuous improvement activities.- Drive and Maintain required housekeeping (5s) standards.- Support the implementation of operations staff training and development programmes to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives.- Support & assist with investigations to determine root cause and support for CAPA implementation- Review & update manufacturing batch records for commercial operations to ensure compliance with cGMP.- Technical Support for Operations and promotion of latest best practice for continuous improvement.- Support of equipment FAT, SAT, qualification & training.- To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities and responsibilities.

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _
- Opportunity/Affirmative_
- Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._



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