What would your job be like at Scilife?
This role is responsible for managing the validation of new systems as well as changes to existing systems by working closely with the development team and functional stakeholders to achieve a culture of continuous improvement along with ensuring CSV requirements are met.
The CSV Manager will oversee GxP impacting projects to ensure that all applicable regulatory, quality, security, data privacy, and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.
- Well conversant with Good Automated Manufacturing Practice (GAMP5), Code of Federal Regulations (specifically 21 CFR part 11), Eudralex volume IV, Annex 11: Computerised Systems and General Data Protection Regulation (GDPR)GAMP5, 21 CFR Part 11 requirements for CSV & GxP practices.
- Provide desired support related to computer system validation and Quality Assurance tasks.
- Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., User Requirements Specification, Functional Specifications, Risk Assessments, Traceability Matrix, Configuration Specifications, IQ, OQ, PQ).
- Work as part of the project team to plan, monitor & review all validation & quality deliverables of the project to ensure compliance with SOPs & regulatory requirements (such as 21CFR Part11 & Annex11) to ensure timely closure of the project.
- Involved in the preparation and checking of validation-related protocols, reports, plans, etc.
- Ensures business requirements are met in the final solution.
- Assisting with the development and maintenance of SOPs, Guidelines, Policies, and supporting forms and templates.
- Basic knowledge of Infrastructure and GMP principles
- Handling of Customer queries related to CSV validation
- Assisting in routine CSV and Quality related activities
What you will need:
- Minimum 5+ years of regulated industry experience and regulatory understanding (21CFR820, 21CFR11, Annex 11, GAMP, HIPAA, etc.)
- Education equivalent to a bachelor's degree in an appropriate discipline.
- Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products.
- Detailed technical understanding of computer system validation and
infrastructure qualification, including the application of risk-managed approaches.
- Experience in the utilization of risk analysis tools such as FMEA, FTA, etc.
- Experience in hosting/defending external audits and regulatory inspections.
- Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc.
- Expert at managing complexity and multiple work streams in changing circumstances.
- 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.
- Reaches across the enterprise to solve problems.
Scilife created the Smart Quality Platform to help people and organizations transform quality into a catalyst for value creation, making quality a culture and infusing it throughout the entire organization. Our technology helps them get their products and services to market fast while complying with regulatory requirements by providing them with a compliant SaaS solution.
Founded in 2018, Scilife is a leading innovator SaaS in quality management solutions for Life Sciences industries. Hundreds of leading companies worldwide like Biocartis, Yusen Logistics, Polpharma, Pendulum, just to name a few, trust Scilife to manage their quality processes, empower employees to take quality ownership, enhance efficiency and transparency, and reduce compliance risk. The impact? Improve patients’ lives.
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