Website PCI Pharma Services
This Job Listing is about PCI Pharma Services in Tredegar,Wales,UnitedKingdom 2022 posted on jobz2day.com
About the job
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 ensure that all quality aspects of developmental analytical activities on the Tredegar site are in compliance with current Good Manufacturing Practise standards in accordance with company policies to meet business requirements.
To ensure the timely release of product by the review of the critical process parameters of the analytical documentation (as defined) to assess the quality, safety and efficacy of the products prior to Qualified Person certification.
To assist in process and departmental audits against the relevant GMP standards to ensure continued compliance and improvement of systems and processes
- To assist the Quality Management team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with current Good Manufacturing Practice standards in accordance with company policies to meet business requirements
- To work with primarily, the Development department to Ensure analytical raw data for GMP applications is in compliance to GMP throughout the analytical development group
- Support the standardisation of documentation across the development group to ensure the review process can be consistently applied.
- Adhere to project timelines
- Ensure analytical raw data for GMP applications is in compliance to GMP throughout the analytical development group
- To perform analytical documentation review of the critical process parameters of testing to ensure compliance with written specifications, SOP’s and GMP.
- To provide KPI’s for Right First Time and manage priorities/workload to ensure that reviews are carried out in a timely manner to meet customer expectations.
- To ensure that, following QA review, analytical documentation is suitable for progression to the QP.
- To comply with internal and external Health and Safety and environmental standards as required.
- Assist with internal and external audits.
- Assist in the review and approval of all documentation relating to development activities to support their continued processes to meet business needs.
- To liaise with the development groups regarding relevant compliance topics.
- Review and approval of stability trend reports.
- Review and approval of deviations raised during method validation
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.