Operations Compliance Coordinator

at  PCI Pharma Services

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.
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

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, Diversity, Equity, and Inclusion (DEI) 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

• 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