Gcp & Pv Qa Manager 100% (f/m/d)
United Arab Emirates, United Arab Emirates
Job Description
***This position can be based in Pxc3xb5lva, Cairo, Sxc3xa3o Paulo, Kyiv***
Job Purpose
QMS maintenance, development and oversight
Job Purpose
- Responsible for the compliance of clinical trials with ICH-GCP, applicable regulatory guidelines, company SOPs.
- Development and maintenance of the Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) related Quality Management System (QMS).
- Performing GCP and GVP related audits and CAPA agreement and follow-up after audits and inspections.
- Provides oversight regarding ongoing QA processes regarding GCP and PV.
QMS maintenance, development and oversight
- Manage, advance, and develop the QMS related to GCP and GVP, including refinements of applicable Quality Manuals.
- Guide the development, maintenance, and quality oversight of GCP and GVP SOPs and related documents (e.g., Safety Management Plans, PV Agreements, Master Service Agreements across clinical trials and post-marketing programs).
- Develop and maintain the governance structure and assess the effectiveness of the QMS.
- Develop, guide and continuously improve Quality Risk Management for risk-based audits of the GVP and GCP related processes or systems.
- Can advise GPV and RA Development & Strategy in the development of conditional reminders and alerts (simple automation tasks in alignment with IT).
- Supports the development of Audit Plans in the field of PV and GCP.
- Can act as developer or tester for the system / process risk-based audit planning of PV vendors.
- Defines the scope of GCP and PV audits, including process audits, CRO audits, site audits, qualification audits.
- Leads GCP and PV audits in the role as lead auditor.
- Reviews audit reports, suggested CAPA and approves CAPA plans in collaboration with GPV, local PV, CTM, and Head of RA Development as applicable.
- Guides and evaluates CAPA development, agreement and follow-up following audits and corresponding Root Cause Analysis.
- Prepares for inspections and responds to inspection findings in the field of GCP and GVP.
- Qualifies and certifies GCP and GVP auditors and establishes corresponding qualification procedures along with the Head of Compliance.
- Performs PV availability (business continuity) testing with relevant PV contacts, website, fax, etc. twice a year as per business continuity requirements.
- Designs, supports and conducts internal trainings in the field of GCP, Pharmacovigilance, and QMS documents as needed.
- Performs QA check on training matrix regarding the assignment of PV SOP to PV staff (and PV-QA).
- Participates in cross-functional teams providing GCP and GVP advice and guidance.
- Can support onboarding activities for CQA colleagues.
- Discusses and reviews deviations in the field of GCP and PV and subsequent CAPAs (acting as an assigned responsible QA Approver in Trackwise).
- Involved in reporting and classification of Quality Incidents in clinical trials and PV.
- Define thresholds for KPIs and trend-based deviations.
- Performs quarterly QA checks of PSMF.
- Can be involved in Safety Bord meetings in case a safety signal with potential impact on product quality is discussed (signal detection) and can revise / approve corresponding communication plans.
- Can act as a QA Approver for Labelling changes in TrackWise/eQMS Change Control (Change category labelling).
- Development and administration of PV-QA Team in MS Teams / SharePoint, to track information and for collaboration regarding PV audits and auditors.
- Liaises with QP-PV regarding concerns, CAPAs, deviations, audits, etc. where needed.
- Member of the Clinical Trial Committee (CTC) and the Clinical Trial Project Team (CTT) with corresponding responsibilities.
- Can create, modify reports / dashboards for metrics & KPIs in the field of GCP and PV in alignment with company KPI management. Capable to model database in Power BI, create corresponding URS.
- Development and administration of GCP-QA Team in MS Teams / SharePoint, to track information and for collaboration regarding PV audits and auditors.
- Acts in line with ACINO principles and values.
- Accuracy and attention to detail.
- Proactive and independent learner to adapt regarding changes in the regulatory and company environment.
- IT skills in Office 365 environment (e.g., regarding SharePoint functionalities), preferably ability (or willingness to learn) DAX for Power BI and/or Power Automate.
- Resilient, when confronted with a complex scope of tasks under challenging timelines and motivates co-workers.
- Excellent communication skills with high impulse control and presence with Business Partners.
- Education: Degree in biomedical, life-sciences (Medicine/ Pharmacy/ Veterinary/ Pharmaceutical Sciences/ Biology), Chemistry or related sciences.
- Languages: Good written and oral knowledge of English.
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Job Detail
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Job IdJD1841727
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationUnited Arab Emirates, United Arab Emirates
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EducationNot mentioned