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Operations Technical Writer
3 months ago
Job ID: JR111547
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.
General Purpose Of Role:
To perform a Quality Operational role which supports:
- Management and execution of all Quality Investigations and procedural updates that are the responsibility of the operational departments.
- Maintain, support and improve the Pharmaceutical Quality System employed within PCI, specifically to improve procedures and implement CAPA's in relations to Operations procedures and processes, with zero overdue without an extension.
- Collate and manage operations KPI's and metrics.
- A lead user for site QMS system within Operations.
Main Responsibilities:
- Support Operations with investigating and drafting Quality Event Investigations within standard timelines and capture temperature excursions for shipments.
- Ensure timely completion of deviation investigations in conjunction with Operations, PM, QC and QA departments.
- Support Operations in completing CAPA actions within standard timelines working with the appropriate departments to facilitate deviation closure.
- Administration, control and support core systems within the Pharmaceutical Quality System as allocated by department manager. Including but not limited to: QIR/complaints, CAPA, Change control and document control systems.
- Work closely woith Operational personnel to develop departmental technical writing skills and imporve processess and procedures.
- Reporting of metrics for systems within scope of responsibility, e.g Client QBR support.
- Provide despatch data for QBRs as requested by Project Managers. Gather data from reports and provide despatch information for relevant protocols from all PCI required sites for the QBR slides.
- Data gathering for Operations activities for efficiencies and business reviews. Provide related data across PCI BGD, PCI DUB and PCI BER.
- Support European sites with SOPs, WI, form creation / updates and any operational process changes/updates related. Working with Senior European Distribution Manager to align site processes (when possible)
- Support with ERP activities in regards to Raising, Despatch and Receipt to ensure Sales Orders and Purchase Orders can be processed within time lines.
- Support with ERP activities in regards to Raising, Despatch and Receipt to ensure Sales Orders and Purchase Orders can be processed within time lines.
- Carry out H&S Risk Assessments for Warehouse and distrbution areas at Bridgend
- Provide information and give feedback on progress of deviations/investigations that may impact batch release.
- Attend deviation meetings and give appropriate feedback for deviation status and progression
- Support delivery of site Operational projects and objectives.
- Support the site's Continuous Improvement activities and maturity index through the one PCI intiative.
- Write operational related standard operating procedures, SOI's and WI.
Outcomes Of Role:
- Co-ordinate and perform Investigations into internal and external quality issues.
- Submission and approvals of completed investigations, CAPA's and change controls.
- Complete procedureal updates to controlled Operational documentation including but not restricted to SOP's, SOI's and Forms.
- Operational reporting and metrics on time and greater than target.
