Operations Compliance Coordinator

PCI Pharma Services

Posted on: October 30, 2024

Closing: November 29, 2024

Position Type: Full Time

Job Description

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.

 

Job Title: Operations Compliance Coordinator

 

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 and Change Control 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 with Operational personnel to develop departmental technical writing skills and improve 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.
  • 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, SOIs and WI.
  • Change projects: for all operations change projects, initiate and drive the change until completion. Requires close collaboration with other functions and stakeholders, in particular qualification/validation.

 

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).
  • Proven experience in warehousing, production, pharmaceutical manufacturing under GMP-regulated conditions, ERP and eQMS and project management is an advantage
  • Fluent in English and German

PCI Pharma Services

Posted on: October 30, 2024

Closing: November 29, 2024

Position Type: Full Time

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