Operations Compliance Coordinator
Grossbeeren, Germany
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
Apply
Career Focus: Operations, Quality, Regulatory/Compliance
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