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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