Operations Technical Writer

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 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 initiative. 

• 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 procedural 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 

Specific Qualifications: 

A HND or equivalent in a business, quality or life sciences subject and / or suitable experience within an operational, quality assurance or technical role within the pharmaceutical industry. 

Previous Work Experience: 

Essential  

Meets one of the following requirements: 

• Experience in a Quality/Technical role within a regulated industry (pharmaceutical, biotechnology, medical device). 

• Experience in a Quality Assurance/Technical Writer role within a regulated industry with transferable skills (e.g. Aerospace, food, automotive) 

• Experience of technical writing, Root Cause Investigation and implementation of CAPA. 

Desirable 

• Knowledge of cGXP, regulatory requirements and appropriate ISO standards. 

• Experience of Investigational Medicinal Products, Biotechnology and EU/US clinical trials is highly desirable. 

Specific Knowledge / Skills Competence: 

• Strong written and verbal communication skills. 

• The ability to introduce, co-ordinate, complete and report on projects. 

• A high level of self-motivation is required 

• Able to rationally persuade and positively Influence  

• Ability to manage conflict and make sound scientifically based decisions. 

• IT literate (experience of e-QMS/document management systems and ERP systems desirable). 

Behavioral Competencies: 

Communication skills – Must be able to communicate at all levels (internally and externally), using different methods and techniques ranging from written reports to formal presentations. 

Interpersonal skills – Able to form and maintain relationships at all levels is essential.. 

Thinking and decision making – The successful candidate often need to make decisions and advise on appropriate courses of action in the event of a Quality incident or to agree appropriate Corrective and Preventative actions.  

The role includes the requirement to occasionally travel on company business. 

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