Operations Technical Writer

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 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.

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.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.