Official Specifications
Role Overview & Mandate
Executive Summary
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are...
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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 Project Management department within the European region
- Maintain, support and improve the Pharmaceutical Quality System employed within PCI, specifically to improve procedures and implement CAPA’s in relations to PM procedures and processes, with zero overdue without an extension.
- Maintain, support and improve completion of NMRs raised to ensure on time delivery of tasks and service
- Collate and manage KPI’s and metrics and provide for Business Review Meetings.
- A lead user for site QMS system within Project Management.
Main Responsibilities:
- Support Project Management with investigating and drafting Quality Event Investigations within standard timelines
- Ensure timely completion of deviation investigations in conjunction with Operations, PM, QC and QA departments.
- Support 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, NMR and document control systems.
- Work closely with personnel to develop departmental technical writing skills and improve processes and procedures.
- Reporting of metrics for systems within scope of responsibility, e.g Client BRM 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 projects and objectives and be a representative for Project Management
- Support the site’s Continuous Improvement activities and maturity index through the one PCI initiative.
- Write Project Management related standard operating procedures, SOI’s and WI.
- Ensure Training modules are kept up to date based on CAPAs implemented.
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).
Join us and be part of building the bridge between life changing therapies and patients.
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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.
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.
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