Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
About the role
- Senior eCSV Analyst managing GxP impacting projects in computerized systems within Convatec. Overseeing compliance, validation, and quality management for healthcare products.
Responsibilities
- The Senior eCSV Analyst will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems.
- Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provide guidance on the risk-based validation approach for the system.
- Work closely with the project manager to ensure all compliance milestones are met during the project lifecycle.
- Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc.
- Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
- Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of products.
- Coach the implementation teams in the proper execution of validation documents.
- Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting.
- Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls.
- Ensure initiation/preparation and closeout of all eCSV related deviations.
- Supply accurate KPIs to management on project compliance status.
- Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change.
- Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement.
Requirements
- A good engineering background with a focus on equipment/process validation.
- Understand of equipment which are controlled by PLC as part of a production line.
- Strong understanding of GXP Regulations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.)
- Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
- Detailed understanding of equipment/process validation.
- Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (QMS), Laboratory Information Systems (LIMS) Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.
- Ability to rapidly adapt to new situations and environments.
- Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
- Ability to influence, negotiate, and constructively challenge to achieve productive solutions.
- Ability to handle a high concentration of work through successful multitasking & prioritizing.
- Conscientious and highly committed, with a dedication to quality.
Benefits
- Equal opportunities
- Health insurance
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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